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

Catalog Number 06699430001

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Dizziness (2194)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that the bolus recommendations provided by the blood glucose monitor are not accurate.The patient received an estimated blood glucose result of 170 mg/dl around 6:30 a.M.And the bolus recommendation was 2.5 units of insulin based on the blood glucose result.The patient thought the recommendation was too much, but she delivered 3 units of humalog injection.The patient started to experience symptoms of disorientation associated with low blood glucose.She was able to consume food and drink on her own to increase the blood glucose level without outside assistance.The patient believed a 2.0 units recommendation would have been appropriate on the blood glucose monitor.

Manufacturer Narrative

Correction - the catalog and unique identifier numbers were updated in section d4 based on the returned product.

• Brand Name: ACCU-CHEK ® AVIVA EXPERT
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18915399
• MDR Text Key: 337799717
• Report Number: 3011393376-2024-00634
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702575103
• UDI-Public: 00365702575103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 06699430001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: HUMALOG INSULIN
• Patient Age: 62 YR
• Patient Sex: Female