MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); No Code Available (3191)

Event Date 08/26/2020

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

The customer reported via phone call that they believe the pump is malfunctioning. The customer constantly treated they high blood glucose levels. The customer felt sleepy and decided to rest. The customer stated they became unresponsive from their low blood glucose and the customer¿s husband called 911. Blood glucose reading 49 mg/dl. The customer was hospitalized for low blood glucose. Customer was admitted to the emergency room on (b)(6) 2020 for an unknown period of time. Blood glucose reading was below 20 mg/dl at the time of admission to the emergency room. Customer was treated with iv insulin drip. The user alleged the insulin pump was over delivering insulin due to customer alleging pump says malfunctioned since they started having high blood glucose levels and thought the pump delivered too much insulin. The customer also mentioned that the pump had been exposed to strong magnetic fields when they had an x-ray. The date of the x-ray exposure was unknown but was months ago. Customer has been using insulin pump system within 48 hours of reported low blood glucose. The customer¿s blood glucose at the time of the call was 129 mg/dl. The insulin pump will be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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
• 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 Key: 10486600
• MDR Text Key: 205456676
• Report Number: 2032227-2020-171464
• 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,Followup
• Report Date: 09/29/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/03/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device LOT Number: HG2F92Q
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/03/2018
• 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: 09/03/2020 Patient Sequence Number: 1

Treatment

FRN-MMT-332-RSVRUNOMED INF SET