BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2112022 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02985
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO SYMPTOMS AT THE TIME OF AN AVIVA SYSTEM RESULT OF 175 MG/DL. TEN MINUTES LATER, HUSBAND FOUND CUSTOMER HAVING SYMPTOMS OF HYPOGLYCEMIA. CUSTOMER WAS INCOHERENT, HER EYES WERE DILATED, CUSTOMER WAS UNABLE TO SPEAK CLEARLY, CUSTOMER WAS UNABLE TO STAND, SHE ALSO HAD A TWITCHING ON HER ARM. CUSTOMER WAS BELLIGERENT AND VERY SWEATY. DAUGHTER TESTED CUSTOMER USING CUSTOMER'S NON-ROCHE SYSTEM, RESULT WAS 21 MG/DL. DAUGHTER TREATED CUSTOMER WITH ORANGE JUICE, A GLUCOSE TABLET, AND PEANUT BUTTER. CUSTOMER STARTED TO FEEL BETTER AN HOUR LATER. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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 303181

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR HUMALOG| RHINOCORT| COENZYME Q-10| HUMULIN N| SPIRIVA| ALBUTEROL SULFATE| ADVAIR DISKUS| MULTIVITAMIN| LANTUS| PROAIR HFA