MAUDE Adverse Event Report: MEDTRONIC MINIMED BATTERY CAP; CGM

Model Number MMT-638B

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Hyperglycemia (1905)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

The customer had a battery cap problem on the insulin pump.The customer's blood glucose level was 411 mg/dl.The customer was treated and she feel ok to troubleshoot.The customer stated that the battery fell out of the insulin pump and their is no battery on it.The customer stated that their is no physical damaged on the insulin pump, just the battery cap fell or loosen.The customer was advised that we will sent replacement for battery cap and retain a copy of their pump settings because it may erase after 24-48hrs of no battery.No further assistance needed.

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.

• Brand Name: BATTERY CAP
• 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: 4308245
• MDR Text Key: 5212794
• Report Number: 2032227-2014-62936
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• 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: 11/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-638B
• Device Catalogue Number: MMT-638B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2014
• 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): Life Threatening
• Patient Age: 49 YR
• Patient Weight: 88