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

Model Number MMT-7705NA

Device Problem Charging Problem (2892)

Patient Problem Hyperglycemia (1905)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported that the customer's blood glucose level was 553 mg/dl.The customer treated himself with insulin.The customer stated his battery charger was not charging properly.The product has been returned.Nothing further was reported.

Manufacturer Narrative

The unit passed functional testing.No charge anomaly was noted.

• 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: 4272658
• MDR Text Key: 5028373
• Report Number: 2032227-2014-56110
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2014
• 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 Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 83