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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 Problem Break (1069)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
Event Date 03/19/2022
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 dispatched through medical emergency services and hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2022. The customer¿s blood glucose level was 880 mg/dl at the time of incident. The customer¿s current blood glucose value was 286 mg/dl. The customer passed out due to high blood glucose. The customer treated high blood glucose with insulin drip. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer stated that the insulin pump had physical damage. No further patient complications were reported. Troubleshooting was performed; however, the customer will discontinue use of the device.
 
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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 Key13895882
MDR Text Key288516822
Report Number2032227-2022-171457
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 Consumer
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
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 NumberHG1TKMR
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2017
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
Treatment
FRN-UNK-RSVR, UNOMED INF SET
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