BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4243599 · Received November 11, 2014

    Report

    Report Number
    1823260-2014-08773
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    July 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    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

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS ON AVIVA SYSTEM COMPARED TO A PROFESSIONAL METER WITHIN 10 MINUTES: "IN THE 400'S" MG/DL (AVIVA SYSTEM) AND "IN THE 200'S" MG/DL (PROFESSIONAL METER). THE EXACT READINGS WERE NOT AVAILABLE. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727066 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493748

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female NOVOLOG MIX 70/30| NOVOLOG MIX 70/30