MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-874T SURETPRDGM 2PK 8MM23N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-874T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 04/04/2020

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

Customer reported via phone call that they experienced blood glucose levels of 41 mg/dl due to a possible over delivery of insulin from their insulin pump.The customer treated their blood glucose levels with food.Customer reports that the programming is inaccurate.Customer was assisted with troubleshooting and the insulin pump worked as designed.No products were returned for analysis.

• Brand Name: INFST MMT-874T SURETPRDGM 2PK 8MM23N 21L
• 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: 9930751
• MDR Text Key: 186679190
• Report Number: 2032227-2020-102183
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-874T
• Device Catalogue Number: MMT-874T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR