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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 Death (1802); Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Coma (2417)
Event Date 03/18/2018
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 hospital. The customer was hospitalized on (b)(6) 2017. The cause of death was a seizure attack and a diabetic coma. The caller stated that they did not know if the customer had any other illnesses that may have led to the customer's passing. The customer¿s blood glucose was 26 mg/dl at the time of admission. The customer was not wearing the insulin pump at the time of death. The insulin pump had been disconnected more than 48 hours prior to passing, at the time of admission. The caller stated the customer was taken off the pump and put on intravenous insulin. The customer was not using sensors. The customer went to sleep on (b)(6) 2017 and never woke up again. The caller declined to return the insulin pump for analysis.
 
Manufacturer Narrative
The information related to date of hospitalization and date of passing provided with initial report was incorrect. (b)(4).
 
Event Description
The correct date of hospitalization is (b)(6) 2018 and customer passing was on (b)(6) 2018. The customer went to sleep on march 17, 2018 and never woke up again.
 
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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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key10776013
MDR Text Key214286838
Report Number2032227-2020-200047
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 consumer
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1E58P
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2016
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: 11/02/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET.
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