BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2931516 · Received January 28, 2013

    Report

    Report Number
    1823260-2013-00459
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 7, 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
    MI, 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: 359 MG/DL, 250 MG/DL, AND 130 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CUSTOMER DOES NOT ALWAYS CODE THE METER PROPERLY. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37584 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491204

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female AMARYL 1X DAILY| AUTOCODE GLUCOSE METER| GLUCOTROL 1X DAILY| LIPITOR| PACEMAKER| PACERONE| PLAVIX| TOPROL| PLAVIX| PACERONE| TOPROL| GLUCOTROL 1X DAILY| PACEMAKER| AUTOCODE GLUCOSE METER| AMARYL 1X DAILY| LIPITOR