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

Model Number MMT-7705NA

Device Problems Difficult to Insert (1316); Charging Problem (2892)

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

Event Date 05/10/2014

Event Type  malfunction  

Manufacturer Narrative

Unable to charge.Problem isolated to board.

Event Description

It was reported that the charger did not work and there was an insertion site issue.The blood glucose reading was 94 mg/dl.The issue was not resolved with a new battery.The customer was using the proper methodology for site insertion.No further information was provided.

• 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: 4021876
• MDR Text Key: 19452433
• Report Number: 2032227-2014-09688
• 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
• Report Date: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• 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: 07/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2014
• 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: 59 YR
• Patient Weight: 100