BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3063641 · Received April 17, 2013

    Report

    Report Number
    1823260-2013-02340
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 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
    AR, 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: 229 MG/DL, 178 MG/DL, 111 MG/DL, AND 109 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
    165142 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491358

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male ALFUZOSIN 1X DAILY| ALLERGAN EYE DROPS 2X DAILY| AMAZING ORANGE JUICE 1X DAILY| ASPIRIN 1X DAILY| DALIRESP 1X DAILY| DIPHENHYDRAMINE 1X DAILY| EQUATE VISION FORMULA| FUROSEMIDE 2X DAILY| GABAPENTIN 1X NIGHTLY| GUAIFENESIN 2X DAILY| IBUPROFEN| IRON TABLETS| ISOSORBIDE 2X DAILY| MULTIVITAMIN 1X DAILY| NITROGLYCERIN| NOVOLOG| NOVOLON N| PORTABLE OXYGEN| POTASSIUM CHLORIDE 2X DAILY| SIMVASTATIN 1X DAILY| SYNTHROID 1X DAILY| TUSSIN DM| TUSSIN DM| POTASSIUM CHLORIDE 2X DAILY| MULTIVITAMIN 1X DAILY| PORTABLE OXYGEN| EQUATE VISION FORMULA| DALIRESP 1X DAILY| GUAIFENESIN 2X DAILY| NOVOLOG| ALLERGAN EYE DROPS 2X DAILY| ALFUZOSIN 1X DAILY| FUROSEMIDE 2X DAILY| NITROGLYCERIN| ASPIRIN 1X DAILY| GABAPENTIN 1X NIGHTLY| NOVOLON N| SYNTHROID 1X DAILY| IBUPROFEN| AMAZING ORANGE JUICE 1X DAILY| SIMVASTATIN 1X DAILY| DIPHENHYDRAMINE 1X DAILY| ISOSORBIDE 2X DAILY| IRON TABLETS