BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2992039 · Received March 7, 2013

    Report

    Report Number
    1823260-2013-01364
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2013
    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
    CA, 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: 438 MG/DL, 85 MG/DL, AND 68 MG/DL. CUSTOMER STATES HE FELT SHAKY AT THE TIME OF THE READINGS, AND SELF-TREATED WITH ORANGE JUICE. HE FELT BETTER RIGHT AWAY, AND TESTED AT 157 MG/DL APPROXIMATELY 8 MINUTES AFTER THE TEST OF 68 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
    97592 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491363

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male HUMALOG| LANTUS| LIPITOR 1X DAILY| PLAVIX 1X DAILY| HUMALOG| LIPITOR 1X DAILY| PLAVIX 1X DAILY| LANTUS