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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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Cardiac Arrest (1762); Fall (1848); Hypoglycemia (1912); Unspecified Heart Problem (4454); Renal Impairment (4499)
Event Date 01/08/2022
Event Type  Death  
Event Description
It was reported via phone call that the customer passed away in hospital. The customer was hospitalized on (b)(6) , 2021 because they feel that they were injured and the sugar drooped to 30 mg/dl. The customer think that cause of death was cardiac arrest and they hasn't got death certificate. Customer has fallen and found he had injury to cervial spin which caused is diaphragm stopped working. The caller stated that the customer had heart circulation issue and kidney issue that may have led to the customer's passing. The customer¿s blood glucose was 30 mg/dl at the time of death. The customer was wearing the insulin pump at the time of death. The customer was using sensors. It was unknown whether the insulin pump was on auto mode or not during the event. The caller it is unknown , if the caller will return the insulin pump for analysis.
 
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.
 
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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 Key13408658
MDR Text Key284788744
Report Number2032227-2022-107416
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 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
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 NumberHG5UGCY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2021
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: 02/01/2022 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET.
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