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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KL
Device Problems Insufficient Flow or Under Infusion (2182); Power Problem (3010)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
(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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that they were experiencing high blood glucose. Blood glucose level at the time of the incident was 400 mg/dl which was treated with manual injections. Customer was alleging insulin pump for under delivery. Customer stated that insulin pump did not recognized new battery. Insulin pump passed displacement test. Customer was experiencing high blood glucose symptom like no energy. Customer was using insulin pump within 48 hours of high blood glucose incident. The insulin pump will be returned for analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715KL 630G
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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key12286083
MDR Text Key265352248
Report Number2032227-2021-177317
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000316655
UDI-Public(01)000000763000316655(17)230925
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG4Q04W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2020
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: 08/06/2021 Patient Sequence Number: 1
Treatment
FRN-MMT-332A-RSVR, UNOMED INF SET.
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