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

Catalog Number	06908268001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: on (b)(6) 2024 252 mg/dl and 123 mg/dl and on (b)(6) 2024 217 mg/dl and between 115-125 mg/dl.
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 PLUS TEST STRIPS
• 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; asku; indianapolis IN 46250 1025
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 19706677
• Report Number: 3011393376-2024-01416
• Device Sequence Number: 7751230
• Product Code: NBW
• UDI-Device Identifier: 00365702408104
• UDI-Public: 00365702408104
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101299
• 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,Followup
• Report Date (Section B): 07/21/2025

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 Catalogue Number: 06908268001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 07/21/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/18/2024; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 73 KG