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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 09/02/2020
Event Type  Malfunction  
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

It was reported via phone call that the customer experienced high blood glucose. The customer blood glucose level was 30. 1 mmol/l at the time of incident and current blood glucose value was 32. 6 mmol/l. Customer's other blood glucose value was 9. 1 mmol/l. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer feel extreme fatigue. Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose. Customer reported that they did not allege insulin pump was under delivering. Customer treated with insulin pump. The customer was assisted with troubleshooting and declined for high blood glucose. The insulin pump will be returned for analysis.

 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key10514474
MDR Text Key206321965
Report Number2032227-2020-175172
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device LOT NumberHG3YSXE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/28/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/03/2019
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: 09/10/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET¿
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