BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2111135 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02927
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K060620
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. OTHER: WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 379 MG/DL AND 186 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA 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 DISCARDED, 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 303220

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR NEBULIZER| LISINOPRIL| VENTOLIN