BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    MDR report key: 3775760 · Received April 28, 2014

    Report

    Report Number
    1832816-2014-00036
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 28, 2014
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    PMA / PMN Number
    K102037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD EXPRESSION METER WAS PRODUCING HIGH READING. CALLER STATED THE METER SENT HER TO THE HOSPITAL BECAUSE IT READ 383. SHE SAID SHE SLEEPS IN LATE AND DID NOT HAVE ANYTHING TO EAT THAT MORNING. SHE ONLY TOOK HER DAILY MEDICATION AT 11AM. AT 12:45 SHE TOOK A READING WHICH WAS 383 AND SHE THOUGHT THAT WAS TOO HIGH SO SHE CALLED HER DOCTOR WHO TOLD HER TO CALL 911 SO SHE DID AND 5 MINUTES LATER THE PARAMEDICS ARRIVED, CHECKED HER GLUCOSE AND IT WAS 260. SHE WAS TAKEN TO THE HOSPITAL TO CHECK WHY HER SUGAR WAS A BIT HIGH AND HER BLOOD WORK CAME BACK NORMAL. SHE WAS NOT TREATED FOR HIGH BLOOD SUGAR, BUT WAS GIVEN BENADRYL IN THE IV AND DID NOT KNOW WHY. SHE WAS KEPT IN THE HOSPITAL FOR FEW HOURS AND THEN WAS RELEASED AND WAS TOLD TO SEE HER DOCTOR IN 3 DAYS. SHE WAS NOT HAVING MAJOR SYMPTOMS, ONLY FEELING SICK TO HER STOMACH BECAUSE OF THE HIGH READINGS. HER TECHNIQUE IS GOOD. SHE SAID SHE DID A CONTROL SOLUTION TEST AND THAT WAS OUT OF RANGE BUT WE DID A TEST OVER THE PHONE AND SHE GOT A READING IN RANGE. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254809 GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 B4S1306008

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization