BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3163119 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03538
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 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
    AZ, 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: 89 MG/DL AND 157 MG/DL. CUSTOMER STATED SHE DID NOT FEEL GOOD AND WAS SHOWING SIGNS OF LOW BLOOD SUGAR WITH THE READINGS, BUT WAS ABLE TO SELF-TREAT BY EATING AND CONTINUING NORMAL FOOD INTAKE AND EXERCISE THE REST OF THE DAY, WHEN SHE STARTED TO FEEL BETTER. CUSTOMER SAID SHE SKIPPED ONE DOSAGE OF LANTUS BECAUSE OF THE READINGS. 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
    263406 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491604

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female ALBUTEROL| BREATHING MACHINE| CIPROFLOXACIN| LANTUS| METFORMIN| METOPROLOL| MUCINEX| PAXIL| SIMVASTATIN| TEGRAL| TRAZODONE| ALBUTEROL| TRAZODONE| PAXIL| LANTUS| METFORMIN| MUCINEX| BREATHING MACHINE| METOPROLOL| SIMVASTATIN| TEGRAL| CIPROFLOXACIN