BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 24969097 · Received April 23, 2026

    Report

    Report Number
    1823260-2026-01565
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACCU-CHEK INFORM II METER SERIAL NUMBER WAS (B)(6). THE REPORTER MENTIONED THAT QC WAS PERFORMED ON THE DAY OF THE EVENT, AND IT WAS REPORTEDLY ACCEPTABLE. THE ACCU-CHEK INFORM II 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 RESULTS HAVE PASSED THE INTERNAL INSPECTION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NO CUSTOMER MATERIAL WAS RECEIVED FOR INVESTIGATION. NO INFORMATION WAS PROVIDED THAT WOULD POINT TO A CAUSE FOR THE DISCREPANCY IN THE RESULTS. THERE WAS NO EVIDENCE OF A CAUSAL LINK TO THE MEDICAL DEVICE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE REPORTER COMPLAINED OF QUESTIONABLE GLUCOSE RESULTS FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER. IT WAS ALLEGED THAT THE METER RESULTS WERE: AT 7:17 AM: 16 MG/DL. AT 7:19 AM: 11 MG/DL. AT 7:29 AM: 146 MG/DL. THE RESULT OF 146MG/DL WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95815 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 671959 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1