BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2970379 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01088
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    October 31, 2012
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 2. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 300 MG/DL AND 40 MG/DL ON AVIVA SYSTEM 1, 102-105 MG/DL ON AVIVA SYSTEM 2 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
    73574 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female GLYBURIDE| JANUVIA| METFORMIN| GLYBURIDE| JANUVIA| METFORMIN