MAUDE Adverse Event Report: MEDTRONIC MINIMED BATTERY CHARGER MLINK; CGM

Model Number MMT-7705NA

Device Problems Corroded (1131); No Display/Image (1183); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

It was reported the customer was unable to charge their transmitter.Customer stated there was corrosion inside the charger for their transmitter.The customer also stated the battery compartment was corroded.It was also found the customer had a blank display on their insulin pump.Customer's blood glucose was unknown.No additional information provided.

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Manufacturer Narrative

The minilink battery charger was unable to charge due to corroded electronic assembly and battery spring contact.

• Brand Name: BATTERY CHARGER MLINK
• Type of Device: CGM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4502782
• MDR Text Key: 5334940
• Report Number: 2032227-2015-05980
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7705NA
• Device Catalogue Number: MMT-7705NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 31 YR
• Patient Weight: 79