BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3943317 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05335
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 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
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 390 MG/DL, 240 MG/DL, AND 120 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423161 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male