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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 11/09/2020
Event Type  Death  
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter. (b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Medtronic received information that legal, possible under delivery anomaly, possible over delivery anomaly occurred. The customer passed away on (b)(6) 2020. The insulin pump malfunctioned due to the retainer ring and locking defect, and failed to deliver the correct dose of insulin to them, causing them to suffer from hyper and hypoglycemia, lose consciousness, and eventually, cardiac arrest and death.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key13873740
MDR Text Key287770766
Report Number2032227-2022-171101
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1R7MD
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
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