MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	05942861001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accu-chek inform ii meter 1 serial number was (b)(6).The accu-chek inform ii meter 2 serial number was not provided.The qc was performed on both meters on the day of the event, and it was acceptable.The test strips were requested for investigation.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing, and the results have passed the internal inspection.The investigation is ongoing.
Event or Problem Description
The reporter complained of discrepant glucose results for 1 patient tested on an accu-chek inform ii meter (meter 1) compared to a different accu-chek inform ii meter (meter 2).The patient was initially tested with meter 1.At 8:21 pm, meter 1 result was 496 mg/dl, and at 8:23 pm, meter 1 result was 234 mg/dl, while at 8:28 pm, meter 2 result was 187 mg/dl.The meter 2 result of 187 mg/dl was believed to be correct.
Additional Manufacturer Narrative
Although two reminders were sent, no customer material was received to carry out a substantial investigation.The investigation did not identify a product problem.

• Brand Name: ACCU-CHEK INFORM II TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24143371
• Report Number: 1823260-2026-00236
• Device Sequence Number: 18391950
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: Health Professional
• Device Catalogue Number: 05942861001
• Device Lot Number: 671812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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: ASPIRIN; CLONIDINE; DEXILANT; DIFLUCAN; DOXYCYCLINE; DULOXETINE; HYDRALAZINE; MUCINEX; XANEX
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG