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

Catalog Number 05520959001

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the battery compartment of the blood glucose monitor showed signs of burning.

Manufacturer Narrative

Correction to field d4 serial number.

• Brand Name: ACCU-CHEK PERFORMA COMBO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10232943
• MDR Text Key: 197590641
• Report Number: 3011393376-2020-02333
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05520959001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 08/03/2020; 01/14/2021
• Supplement Dates FDA Received: 08/25/2020; 01/25/2021
• Patient Sequence Number: 1
• Patient Age: 28 YR