BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2072138 · Received April 28, 2011

    Report

    Report Number
    1823260-2011-02311
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 550 MG/DL, 162 MG/DL, 145 MG/DL AND 143 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT HE TOOK 76 UNITS OF NOVOLIN AND 20 MG OF GLIPIZIDE AS HE NORMALLY WOULD HAVE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 150 MG/DL AND 450 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE STRIPS WERE DEPLETED, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302984

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR NOVOLIN| GLIPIZIDE (TWICE DAILY)