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

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.

• Brand Name: KIT MMT-1762K 670G V4.11 GS3 MM
• Type of Device: ARTIFICIAL 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 Key: 10400037
• MDR Text Key: 202681615
• Report Number: 2032227-2020-161926
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• 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 Received: 08/12/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1762K
• Device Catalogue Number: MMT-1762K
• Device LOT Number: HG3CYE6
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/30/2019
• 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