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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-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hip Fracture (2349); Cancer (3262)
Event Date 01/05/2022
Event Type  Death  
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
It was reported via phone call that the customer passed away in hospice care. The customer was hospitalized on (b)(6) 2021 due to mobility issue. The caller stated that the customer was insulin diabetic, fell and broke their hip that may have led to the customer's passing. The customer¿s had high blood glucose, they had taken morphine and blood glucose went to 593 mg/dl. The customer was wearing the insulin pump at the time of death. The customer was not using sensors. The customer's wife did not felt that it was a pump problem, it was their body shutting down from the cancer, and being sedentary, and the high blood pressure. The caller declined to return the insulin pump for analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key13341291
MDR Text Key284346874
Report Number2032227-2022-105927
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/26/2021
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG2MTSJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2018
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: 01/25/2022 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED SET.
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