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

Catalog Number	06908217001
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case, with patient identifier cn-491024a (system 1), is related to case with patient identifier (b)(6).(system 2).
Event or Problem Description
It was reported the patient received the following sets of results within 15 minutes: system 1: at 9:58am a reading of 357 mg/dl.At 9:59am a reading of 226 mg/dl.At 10:02am a reading of 135 mg/dl.At 10:34am a reading of 354 mg/dl.At 10:35am a reading of 203 mg/dl.At 10:36 am a reading of 164 mg/dl.System 2: at 10:50am a reading of 355 mg/dl.At 10:59am a reading of 202 mg/dl.At 11:00am a reading of 117 mg/dl.

• 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; na; indianapolis IN 46250 1025
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 19812002
• Report Number: 3011393376-2024-01518
• Device Sequence Number: 8379741
• Product Code: NBW
• UDI-Device Identifier: 00365702407107
• UDI-Public: 00365702407107
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 08/21/2024

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: Other
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 06908217001
• Device Lot Number: 690621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 73 KG