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

Catalog Number	06870287001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the meter reads in mmol/l rather than mg/dl.Results in the meter memory indicates that readings are stored as mg/dl.
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: 9175798
• Report Number: 3011393376-2019-03769
• Device Sequence Number: 11733615
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (Y/N): N
• Initial Reporter State: AS
• Initial Reporter Country: US
• PMA/510(K) Number: K043474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• 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 Catalogue Number: 06870287001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 07/22/2025
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/18/2019; 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: 64 YR
• Patient Sex: Female