BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2923878 · Received January 22, 2013

    Report

    Report Number
    1823260-2013-00354
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    July 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 249 MG/DL, HI (RESULT OVER 600 MG/DL) AND 175 MG/DL. CUSTOMER TOOK HALF OF A GLIMEPIRIDE TABLET AFTER GETTING THE HI (RESULT OVER 600 MG/DL). 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
    29688 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490752

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female ADVAIR| ALLOPURINOL - 2X'S A DAY| BUDESONIDE - AS NEEDED| CLONAZEPAM - 1X A DAY| GLIMEPIRIDE| LANSOPRAZOLE - 1X A DAY| LATANOPROST EYE DROPS| MAXALT-MLT - 2X'S A DAY| METFORMIN - 2X'S A DAY| NEBULIZER| OMEPRAZOLE - 1X A DAY| PRAVASTATIN| VITAMIN D| ZOLPIDEM TARTRATE - 1X A DAY| PRAVASTATIN| LANSOPRAZOLE - 1X A DAY| VITAMIN D| LATANOPROST EYE DROPS| METFORMIN - 2X'S A DAY| GLIMEPIRIDE| CLONAZEPAM - 1X A DAY| ADVAIR| ALLOPURINOL - 2X'S A DAY| MAXALT-MLT - 2X'S A DAY| NEBULIZER| ZOLPIDEM TARTRATE - 1X A DAY| BUDESONIDE - AS NEEDED| OMEPRAZOLE - 1X A DAY