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

Catalog Number 06454348018

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

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

The caller reported that at 3:00 am her car alarm went off and she discovered that the performa nano system was on fire in her back seat.Her father was able to put the fire out.However, firefighters were called to the scene and confirmed is was the performa device that was on fire in the car.No adverse event was reported.The serial number was not provided.The blood glucose monitor was requested to be returned for product evaluation.

Manufacturer Narrative

After investigation of the returned device and materials that were with the device at the time of the event along with pictures provided, it was determined that neither the device nor the batteries within the device were the source of the fire.The device showed signs of melting from an external heat source but the internal components of the device including the inserted batteries were in tact with no signs of internal component or circuit malfunction.

• Brand Name: ACCU-CHEK ® PERFORMA NANO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8311905
• MDR Text Key: 135207439
• Report Number: 3011393376-2019-00547
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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: Other
• Device Catalogue Number: 06454348018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1