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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1762K 670G V4.11 GS3 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1762K 670G V4.11 GS3 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1762K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 07/29/2020
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. 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 that they experienced high blood glucose. The customer blood glucose level was 24 mmol/l at the time of incident. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer reported that auto mode feature was active and automatically adjusting insulin delivery at time of high blood glucose event. Customer was feel really tired. The customer was assisted with troubleshooting and declined for high blood glucose. The insulin pump will not be returned for analysis.

 
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Brand NameKIT MMT-1762K 670G V4.11 GS3 MM
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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key10400037
MDR Text Key202681615
Report Number2032227-2020-161926
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1762K
Device Catalogue NumberMMT-1762K
Device LOT NumberHG3CYE6
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/30/2019
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: 08/12/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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