BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4190266 · Received October 21, 2014

    Report

    Report Number
    1823260-2014-08084
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 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
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 335 MG/DL AND 78 MG/DL WITHIN 10 MINUTES ON THE AVIVA PLUS SYSTEM. CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH THESE RESULTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE TEST STRIPS ARE NO LONGER AVAILABLE; REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 335 MG/DL AND 78 MG/DL WITHIN 10 MINUTES ON THE AVIVA PLUS SYSTEM. CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH THESE RESULTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668524 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male UNKNOWN INSULIN| UNKNOWN INSULIN