BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3040038 · Received April 8, 2013

    Report

    Report Number
    1823260-2013-02132
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    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: HI (GREATER THAN 600 MG/DL) AND 144 MG/DL. CUSTOMER WAS ACTING STRANGE AND KEPT FALLING ASLEEP WITH THE READINGS. DAUGHTER ATTEMPTED TO TREAT THE CUSTOMER WITH APPLESAUCE, BUT CUSTOMER WAS TOO SLEEPY AND FELL ASLEEP. 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
    143721 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491351

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female IRON TABLET| METOPROLOL| OXYGEN| SLEEP APNEA MACHINE| SPIRONOLACTONE| TORSEMIDE| WARFARIN| IRON TABLET| WARFARIN| METOPROLOL| SPIRONOLACTONE| SLEEP APNEA MACHINE| OXYGEN| TORSEMIDE