MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7703NA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Pain (1994); Skin Irritation (2076); Blood Loss (2597)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The event was reported in error.

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. Reference manufacturer report number: 2032227-2017-30464.

Event Description

The customer reported via phone call that their site began burning, bleeding, and bruising after 4 days of wearing the sensor. The customer¿s blood glucose level was unknown. Troubleshooting was not performed. The customer also used the transmitter along with the sensor. The product will not be returned for analysis.

• Brand Name: MINILINK TRANSMITTER MMT-7703NA
• 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: 6765936
• MDR Text Key: 188174540
• Report Number: 2032227-2017-34118
• Device Sequence Number: 1
• Product Code: MDS
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-7703NA
• Device Catalogue Number: MMT-7703NA
• Device Lot Number: A000344716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2020
• 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: Unkown

Patient Treatment Data

Date Received: 08/03/2017 Patient Sequence Number: 1