BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2946159 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00721
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 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
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 104 MG/DL (AVIVA SYSTEM 1) AND 383 MG/DL (AVIVA SYSTEM 2). CUSTOMER WAS ABLE TO SELF-TREAT THE HIGH READING WITH INSULIN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49641 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491305

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female HUMALOG| LANTUS| HUMALOG| LANTUS