MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-387T QCKSTPRDGM 2PK 6MM32N; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-387T

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 03/04/2020

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 reported via phone call that they experienced hypoglycemia.The customer's blood glucose level was 40 mg/dl at the time of incident and the another blood glucose 55 mg/dl.The customer was treated with food and glucose tablet for low blood glucose.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Auto mode was automatically delivering the insulin at the time of low blood glucose.The device will be returned for analysis.

• Brand Name: INFST MMT-387T QCKSTPRDGM 2PK 6MM32N
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 9808909
• MDR Text Key: 182652015
• Report Number: 2032227-2020-101686
• Device Sequence Number: 1
• Product Code: FPA
• 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: Other
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-387T
• Device Catalogue Number: MMT-387T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVR
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 148