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

Model Number MMT-7705NA

Device Problem Charging Problem (2892)

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

Event Date 01/31/2015

Event Type  Injury  

Event Description

It was reported that the customer was hospitalized.His blood glucose level was unknown.The customer had issues charging the transmitter.The product will return.Nothing further to report.

Manufacturer Narrative

Reference medwatch 2032227-2014-61284 for additional information.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.

• 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: 4634602
• MDR Text Key: 5594808
• Report Number: 2032227-2015-10995
• 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: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 84