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

Catalog Number	06908268001
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 388 mg/dl, 156 mg/dl, 80 mg/dl, and 52 mg/dl.The patient experienced symptoms of tingling on the back of her neck and lightheadedness at the time of the 52 mg/dl result.The patient was capable of self-treating her hypoglycemia by obtaining and consuming yogurt and saltine crackers without assistance.The patient felt better 30 to 40 minutes after consuming the food.

• Brand Name: ACCU-CHEK ® AVIVA PLUS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21285041
• Report Number: 3011393376-2025-00214
• Device Sequence Number: 7961425
• Product Code: LFR
• UDI-Device Identifier: 00365702408104
• UDI-Public: 00365702408104
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 06908268001
• Device Lot Number: 690724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG INSULIN.; HUMALOG PEN.; LANTUS INSULIN.; LANTUS PEN.; METFORMIN.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 73 KG