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

Catalog Number	06870287001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor displayed a power issue error message on the night of (b)(6) 2019 at an unknown time.Around 12:00 a.M.On (b)(6) 2019, the patient was yelling incoherently.She was still conscious, but was unable to self-treat.The patient's son contacted the paramedics immediately because she was incoherent and not making sense when responding to questions.Upon arriving within 5 to 10 minutes, the blood glucose result was 25 mg/dl on the paramedic's meter.The patient was treated with an unknown substance via iv.The patient arrived at the hospital around 12:45 a.M.Where she was treated with an iv of an unknown substance, food, and juice.The blood glucose result upon arrival at the hospital was not provided.The patient was released from the hospital around 4:00 p.M.On (b)(6) 2019.
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 CORPORATION; 13000 south memorial parkway; na; huntsville AL 35803
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9086886
• Report Number: 3011393376-2019-03452
• Device Sequence Number: 11363350
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 06870287001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 07/22/2025
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 12/16/2019; 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
• Concomitant Medical Products and Therapy/Usage Dates: GLIPIZIDE; METFORMIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 88 KG