BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3103003 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02851
    Event Type
    Malfunction
    Date Received
    May 9, 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
    MO, 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: 268 MG/DL AND 50 MG/DL. THE CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS OF FEELING DIZZY AT THE TIME OF THE RESULTS. THE CUSTOMER CALLED THE EMTS. APPROXIMATELY 20 MINUTES AFTER CUSTOMER'S RESULTS, THE EMT METER READ 147 MG/DL. THE CUSTOMER WAS TESTED AGAIN ON EMT METER 10 MINUTES AFTER THE 147 MG/DL RESULT AND A 61 MG/DL RESULT WAS OBTAINED. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE UNSPECIFIED TESTS WERE RUN. THE CUSTOMER WAS NOT ADMITTED TO THE HOSPITAL AND DID NOT RECEIVE ANY TREATMENT AT THE HOSPITAL. 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
    204380 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491609

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male JANUVIA| METFORMIN| METFORMIN| JANUVIA