MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® ADVANTAGE; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 22138930689

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent a report to the fda.

Event Description

Patient reported the battery contact of the meter shows signs of melting and burning.No adverse event reported.Requested return of the alleged device for evaluation and replacement was sent.

• Brand Name: ACCU-CHEK ® ADVANTAGE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): SANMINA-SCI CORPORATION; 13000 south memorial parkway; na; huntsville AL 35807
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250 ; 3175212484
• MDR Report Key: 5046979
• MDR Text Key: 24770506
• Report Number: 3011393376-2015-03104
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 22138930689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• 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: N
• Patient Sequence Number: 1