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U.S. Department of Health and Human Services

Class 1 Device Recall Mini Med

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  Class 1 Device Recall Mini Med see related information
Date Initiated by Firm November 21, 2019
Date Posted February 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-0955-2020
Recall Event ID 84430
PMA Number P150001 
Product Classification Automated insulin dosing , threshold suspend - Product Code OZO
Product Medtronic MiniMed 630G System with SmartGuard, Ref/Model #MMT-1715
Code Information All Serial Numbers  Expiration Date- 4 years from date of manufacture.
Recalling Firm/
Manufacturer
Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
818-576-3398
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action 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 doctors 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.
Quantity in Commerce 184,478 units
Distribution ***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,
Total Product Life Cycle 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.
PMA Database PMAs with Product Code = OZO and Original Applicant = MEDTRONIC MINIMED
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