BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3100474 · Received May 8, 2013

    Report

    Report Number
    1823260-2013-02824
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 28, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 87 MG/DL AND 192 MG/DL; 192 MG/DL, 105 MG/DL AND 125 MG/DL. RESULTS OF 192 MG/DL WERE NOT DUPLICATED. SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. CUSTOMER WAS FEELING HYPOGLYCEMIC SYMPTOMS OF NERVOUSNESS AND FEELING WARM AT THE TIME OF THE RESULTS. CUSTOMER DRANK ORANGE JUICE AND ATE PEANUT BUTTER CRACKERS BETWEEN THE RESULTS OF 105 MG/DL AND 125 MG/DL. THE CUSTOMER FELT BETTER. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201910 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491617

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female GLIPIZIDE| METFORMIN| METFORMIN| GLIPIZIDE