BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOCARD 01 BLOOD GLUCOSE SYSTEM

    MDR report key: 1840979 · Received September 22, 2010

    Report

    Report Number
    1832816-2010-00020
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ARKRAY FACTORY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS EVALUATED WITH RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD 01 METER WAS GIVING VARIABLE READINGS. MS. (B)(6) TESTED AT 9:19 PM, BG WAS 41, SHE TESTED AGAIN AT 9:20 PM USING A NEW BLOOD SAMPLE AND HER BG WAS 383, AGAIN AT 9:22 BG WAS 341. TECNIQUE USED IS ACCURATE. HANDS WASHED WITH WARM SOAPY WATER, ALCOHOL WIPE USED, HANDS THOUROUGHLY DRIED. SHE WAS NOT FEELING ILL OR LIKE HER BG WAS HIGHER OR LOWER THAN SHOULD BE. NO TREATMENT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOCARD 01 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY FACTORY, INC. 720050 B104A06

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR