MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML; PUMP, INFUSION

Model Number MMT-XXX

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Hypoglycemia (1912); Coma (2417)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

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's wife reported via phone call that they were experiencing low blood glucose and the insulin pump kept pumping so they went into coma, then had a heart attack and then a stroke.Customer stated that they treated with shots.Blood glucose level at the time of the incident was 40 mg/dl which was treated with food.It was unknown that customer was using insulin pump or not within 48 hours of low blood glucose incident.Customer declined to troubleshoot for low blood glucose.The insulin pump and reservoir will not be returned for analysis.

• Brand Name: RESERVOIR 3ML
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325-1219 ; 7635140379
• MDR Report Key: 12299300
• MDR Text Key: 265769324
• Report Number: 2032227-2021-178611
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 63 YR