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

Model Number	06870287001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor was unavailable for use due to power concerns.On the morning of (b)(6) 2019 the patient attempted to test her blood glucose and received an e-9 message.The patient took her normal dosage of medication.At approximately 2:30-3:00 pm the patient was at lunch with friends and stated that she began to feel weird and became unresponsive.The patient attempted to test her blood glucose at this time and received an e-9 message.No restaurant employees or friends provided treatment to the patient, but they called emt's.It was reported that the emt's did not test her blood glucose level on their device, but did treat her with an iv.The contents of the iv were unknown.The patient was transported to the hospital.The blood glucose results received at the hospital were elevated.The type of medication or treatment provided by the hospital was unknown.However, caller reported that she was given her normal medication's.The patient was hospitalized for 4 days.
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) ¿ (b)(4) 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: 9642422
• Report Number: 3011393376-2020-00317
• Device Sequence Number: 19407091
• Product Code: NBW
• UDI-Device Identifier: 00365702544109
• UDI-Public: 00365702544109
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Model Number: 06870287001
• Device Catalogue Number: 06870287001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/28/2020; 07/22/2025
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/18/2020; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ATORVASTATIN; DILTIAZEM; HUMALOG; LOSARTAN; METFORMIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 109 KG