BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3142001 · Received June 3, 2013

    Report

    Report Number
    1823260-2013-03299
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL) AND 107 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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
    245250 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303528

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male AMLODIPINE| DOXAZOSIN| LISINOPRIL| METFORMIN| SIMVASTATIN| AMLODIPINE| DOXAZOSIN| LISINOPRIL| METFORMIN| SIMVASTATIN