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

Model Number 06870287001

Device Problems Fire (1245); Melted (1385)

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

Event Date 05/17/2020

Event Type  malfunction  

Event Description

It was reported device exploded and caught fire and was melted.The patient stated she heard a loud "pop" and saw black smoke and flames coming from her meter carrying case and she doused the meter with water.

Manufacturer Narrative

As apparent during the examination of the returned meter, most of the damage to the meter was to the front area by the strip port.The aviva ii meter uses a 3v battery.This battery type does not have enough voltage/capacity to ignite/explode by itself with an external factor.Per the meter labeling, the meter should not be stored by a heat source.Due to the condition of the returned meter it has been concluded that the damage did not originate from the meter itself and has been determined to be a result of customer mishandling.

• Brand Name: ACCU-CHEK AVIVA
• 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: 10148030
• MDR Text Key: 194940944
• Report Number: 3011393376-2020-02059
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 06870287001
• Device Catalogue Number: 06870287001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 90