MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER MMT-7731 GST3B REPLACEMENT; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7731

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

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 multiple sensor signal not found alarms and the insulin pump had a display was black.The customer¿s blood glucose level was unknown at the time of the incident.The customer was assisted with troubleshooting.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The event was reported in error.

Manufacturer Narrative

The follow up report was submitted with blank.The correct date is 15-apr-2020.

• Brand Name: TRANSMITTER MMT-7731 GST3B REPLACEMENT
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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
• MDR Report Key: 6870000
• MDR Text Key: 86455996
• Report Number: 2032227-2017-48683
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7731
• Device Catalogue Number: MMT-7731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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