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

Model Number	06870287001
Medical Device Problem Codes	Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: ACCU-CHEK ® AVIVA
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI INDIA PVT LTD.; oz-1 sipcot hi-tech sez,oragad; sriperumpudur taluk; chennai, tamil nadu 60210 5; IN 602105
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 10148030
• Report Number: 3011393376-2020-02059
• Device Sequence Number: 2101965
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 07/22/2025
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/14/2020; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 90 KG