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Minimed 620g

  1. Medtronic Minimed 620g
  2. Minimed 620g Insulin Pump
Insulin620g

MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. The FDA approved the MiniMed 530G with Enlite, a breakthrough system, in 2013, as a first-generation artificial pancreas device, communicating with the continuous glucose monitor (CGM) sensors. This was followed with the launch of the MiniMed 620G in Japan in 2014, the 640G outside the United States in 2015, and the 630G in the United States in. September 2015 – MiniMed 620G and 640G pumps recalled due to drive motor and malfunctioning timer; September 2014 – MiniMed Paradigm insulin pump recalled due to programming errors which had resulted in maximum insulin dose being mistakenly delivered; July 2013 – MiniMed Paradigm reservoir recalled due to a problem with priming of the pump. Pose cc sims 4.

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Minimed 620g

Medtronic Minimed 620g

Minimed 620g
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620G/630G/640G/670G Insulin Delivery Pump Users Manual 5 details for FCC ID OH21510 made by Medtronic MiniMed, Inc. Document Includes User Manual Users Manual 5. 1510 620g/630g/640g/670g Insulin Delivery Pump User Manual Users Manual 5 Medtronic Minimed, Inc. 1510 620G/630G/640G/670G Insulin Delivery Pump User Manual Users Manual 5 Medtronic MiniMed, Inc. Medtronic MiniMed, Inc. 620G/630G/640G/670G Insulin Delivery Pump Trouble Viewing?

Minimed 620g insulin pump

Minimed 620g Insulin Pump

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Class 1 Device Recall MiniMed 620G System
Date Initiated by FirmNovember 21, 2019
Date PostedFebruary 07, 2020
Recall Status1Open3, Classified
Z-0957-2020
Recall Event ID84430
Automated insulin dosing device system, single hormonal control - Product CodeOZP
ProductMedtronic MiniMed 620G Insulin Infusion Pump, Ref #, Model #s MMT-1510 and MMT-1710, CE 0459, Rx Only
Code InformationAll Serial Numbers; Expiration Date- 4 years from date of manufacture. ***NOT DISTRIBUTED WITHIN THE US***
Recalling Firm/
Manufacturer
Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactPamela Reese
818-576-3398
There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
Device Design
On November 21, 2019, the firm mailed a 'Urgent Field Safety Notification' letter to patients and health care providers. In addition to informing patients about the recall, the letter ask patients do the following: 1. Examine the retainer ring on your pump. 2. If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, discontinue using the insulin pump and revert to a back-up plan of manual insulin injections per your doctor0019s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a large insulin bolus, and go to www.medtronicdiabetes.com/PumpRing or contact our Medtronic 24-Hour Technical Support line at 1-877-585-0166. 3. If your reservoir properly locks in place by the retainer ring, continue to use your pump. Remember to always follow the Instructions for Use on how to correctly insert the reservoir. PRECAUTIONS RECOMMENDED FOR ALL PATIENTS 1. If by accident you drop or bump your pump, check your pump and retainer ring for damage. 2. Routinely examine your pump retainer ring and check that your reservoir locks in place at every set change. 3. Please visit www.medtronicdiabetes.com/PumpRing for additional information and answers to frequently asked questions.
11,903 units
***MODELS 630G AND 670G DISTRIBUTED US AND OUS*** ***MODELS 620G AND 640G DISTRIBUTED OUS ONLY*** US:AK,AL,AR,AZ,BM,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Republic, Finland, Switzerland, Slovakia, Ireland, Poland, S. Africa, Greece, Hungary, Saudi Arabia, United Arab Emira, New Zealand, Australia, Japan, Mexico, Colombia, Brazil, S. East Asia, Korea, Canada,
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.