MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems No Display/Image (1183); Material Integrity Problem (2978)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 12/01/2020

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

The customer reported via phone call that customer were experiencing high and low blood glucose and insulin pump had blank display. Blood glucose level at the time of the incident was 61 mg/dl and 401 mg/dl. Customer was using insulin pump system within 48 hours of reported high and low blood glucose event. Customer experienced symptom like fatigue. Customer treated with food for low blood glucose. Customer was neither in emergency room nor admitted into hospital. Customer stated battery cap damaged or corroded. The insulin pump will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 10956697
• MDR Text Key: 219853270
• Report Number: 2032227-2020-213525
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/06/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/07/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device LOT Number: HG1N2BP
• 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: 12/01/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/04/2017
• 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: 12/07/2020 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR,UNOMED INF SET