BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD VITAL BLOOD GLUCOSE SYSTEM

    MDR report key: 2972259 · Received February 21, 2013

    Report

    Report Number
    1832816-2013-00012
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD VITAL METER WAS GIVING VARIABLE READINGS. THE CUSTOMER STATED SHE WOKE UP SATURDAY MORNING AND TOOK HER BLOOD SUGAR TEST AND RECEIVED A BLOOD SUGAR OF 48MG ON VITAL METER (B)(4) AND STRIP LOT 12102A. SHE THEN TOOK 1 TABLET OF GLUCOSE GEL AND 3 SUGAR TABLETS. NEXT, SHE ATE A PIECE OF TOAST WITH PEANUT BUTTER. SHE CHECKED HER BLOOD SUGAR ONE HOUR LATER AT 8:42A AND RECEIVED A READING OF 372MG. SHE WANTED TO CHECK IF HER BLOOD SUGAR LEVEL WAS INCREASING AND IF SHE WAS SAFE BECAUSE A BLOOD SUGAR OF 48 IS NOT SAFE FOR HER. AFTER THAT SHE PLUGGED THE 372 IN HER PUMP AND PUMPED INSULIN INTO HER BODY, SHE STATED THE INSULIN AMOUNT IS PROGRAMMED INTO HER PUMP BUT DOESN'T KNOW HOW MUCH INSULIN SHE TOOK EXACTLY. SHE STATED SHE WAITED A LITTLE WHILE THEN HER BLOOD SUGAR DECREASED TOO FAST TO 42MG ON THE VITAL AND THAT IS WHEN SHE DOUBTED HER METER. SHE WAS SHAKING, HAD SEIZURE LIKE QUALITIES AND WAS CONFUSED. HER DAUGHTER THEN HELPED HER BY TURNING HER PUMP OFF AND FED HER MORE SUGAR GEL. SHE STATED IF HER DAUGHTER WASN'T THERE TO HELP HER, SHE DOESN'T KNOW WHAT WOULD HAVE HAPPENED. SHE RECOVERED AFTER THAT. WENT OVER TECHNIQUE; CALLER WASHES HER HANDS EVERY TIME SHE TESTS AND DRIES HER HANDS THOROUGHLY. SHE STATED SHE CHANGES HER LANCETS MOST OF THE TIME BUT NOT EVERY TIME. SHE STATED SOMETIMES SHE HAS TROUBLE GETTING A SAMPLE SIZE OF BLOOD AND USES HER FIRST DROP OF BLOOD. EXPLAINED PROPER STORAGE AND TECHNIQUE. HAS CONTROLS BUT HAS NOT USED THEM. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76629 GLUCOCARD VITAL BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 761103 12102A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening