BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3020547 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01836
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 7, 2012
    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. DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 394 MG/DL AND 179 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, CUSTOMER NO LONGER HAS STRIPS. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124102 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male ABILIFY| ADVAIR| ALBUTEROL| ARICEPT| ATENOLOL| CLOBETASOL PROPIONATE| DEPLIN| FLONASE 2X DAILY| FOSAMAX| LISINOPRIL 1X DAILY| LOPID| METFORMIN| MIRAPEX| NEURONTIN| NIASPAN| PRILOSEC| REQUIP 1X DAILY| SEROQUEL 1X DAILY| SPIRIVA INHALER 2X DAILY| WELLBUTRIN| ZOLOFT| ARICEPT| SPIRIVA INHALER 2X DAILY| ZOLOFT| SEROQUEL 1X DAILY| REQUIP 1X DAILY| MIRAPEX| ALBUTEROL| PRILOSEC| NIASPAN| METFORMIN| LISINOPRIL 1X DAILY| NEURONTIN| FLONASE 2X DAILY| DEPLIN| CLOBETASOL PROPIONATE| ATENOLOL| ABILIFY| FOSAMAX| ADVAIR| LOPID| WELLBUTRIN