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

Catalog Number	08340331001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor was unavailable for use due to an error message.On the morning of (b)(6) 2023 the customer received a blood glucose result of 153 mg/dl at 7:30am.This was a normal blood glucose reading for the customer and he administered his normal 20 units of lantus.Sometime between the timeframe of 12:30 pm and 5:15 pm the customer lose coconsciousness and had a seizure due to low blood sugar.The customer was home alone when he lost consciousness and could not recall the exact time.The customer attempted to test his blood sugar prior to losing consciousness and received an e6 error message on the device.The customer's wife arrived home at 5:15pm and discovered the customer conscious in the bathroom, she attempted to test his blood glucose and again received an error message of e6.The wife then treated the customer with orange juice and peanut butter.At 5:30pm the wife attempted to test the customer's blood glucose again, and finally received a result of 109 mg/dl.The wife drove the customer to the hospital.They arrived at the hospital at 6:15p and the hospital tested the customer's blood glucose and received a result of 240 mg/dl.The hospital performed a series of tests and ran an ekg.No treatment was provided for diabetes.The customer was not admitted into the hospital and went home 2 hours later.
Additional Manufacturer Narrative
Correction d4: catalog no and unique identifier were updated based on the returned product.
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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17410298
• Report Number: 3011393376-2023-01725
• Device Sequence Number: 15326807
• Product Code: NBW
• UDI-Device Identifier: 00365702702394
• UDI-Public: 00365702702394
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/22/2025

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: 08340331001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 07/22/2025
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/16/2023; 07/22/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LANTUS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 83 KG