BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4210847 · Received October 29, 2014

    Report

    Report Number
    1823260-2014-08369
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    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
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN AVIVA METER, COMPARED TO A PROFESSIONAL METER AND TO LAB RESULTS, WITHIN 10 MINUTES: 225 MG/DL (AVIVA), 107 MG/DL (DOCTOR'S METER - TYPE UNKNOWN) AND 107 MG/DL (LAB). NO DEATH OR SERIOUS INJURY REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694016 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female GLIPIZIDE| LOSARTAN| OXYBUTYNIN| OXYBUTYNIN| LOSARTAN| GLIPIZIDE