MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problems Break (1069); Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 01/01/2022

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 low blood glucose. The customer¿s blood glucose level was 44 mg/dl. The customer did not experienced symptoms of low blood glucose value. The customer treated low blood glucose with glucose tablets. The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose. It was unknown if the customer was using auto mode or not at the time of incident. Customer did allege over delivery on the insulin pump. No further complications were reported. The customer will continue to use the device.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 14134201
• MDR Text Key: 289427227
• Report Number: 2032227-2022-180072
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A6751NASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/06/2018
• 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: 04/18/2022 Patient Sequence Number: 1

Treatment

FRN-MMT-332-RSVR, UNOMED INF SET