BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3061296 · Received April 16, 2013

    Report

    Report Number
    1823260-2013-02314
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 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

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 495 MG/DL AND 218 MG/DL WITHIN 10 MINUTES. CALLER REPORTED A SEPARATE COMPARISON ON THE SAME SYSTEM OF 376 MG/DL AND 118 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162155 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491363

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female EYE DROPS| LANTUS SOLOSTAR 1XDAY| NOVOLOG| EYE DROPS| LANTUS SOLOSTAR 1XDAY| NOVOLOG