BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    MDR report key: 5650864 · Received May 12, 2016

    Report

    Report Number
    1832816-2016-00008
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    NBW
    PMA / PMN Number
    K113098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. THE SAME LOT OF TEST STRIPS BELIEVED TO BE INVOLVED IN THE INCIDENT WERE TESTED RECENTLY AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD EXPRESSION METER WAS GIVING HIGH READINGS. DAUGHTER REPORTS THAT ON (B)(6) 2016 @ 10:02 AM SHE TESTED HER FATHER WITH THE GLUCOCARD EXPRESSION METER AND IT READ 578. SHE ASKED HER FATHER IS HE WAS FEELING BAD AND HE WAS NOT. SHE NOTED HE DID NOT HAVE ANY SYMPTOMS OF BEING HI SUCH AS FEVER, VOMITING OR DRY MOUTH. SHE SAID SHE TESTED AGAIN AND THE METER SAID HI. WE DID NOT LOCATE THAT RESULT IN THE MEMORY. SHE ELECTED TO TREAT HIM, BUT AS A PRECAUTION SHE CUT THE DOSE IN HALF. SHE TESTED HIM ON THE ACCUCHECK METER AND GOT 288 @ 10:04AM, 238 @ 11:04AM AND 153@12:06PM. HE RETURNED TO NORMAL ACTIVITY. SHE DESCRIBES THE TESTING PROCEDURE AS USING A COTTON BALL WITH ALCOHOL AND THEN DRYING IT WITH A SECOND COTTON BALL. SHE USES A NEW LANCET EACH TIME. SHE TESTS IMMEDIATELY AS SHE IS AWARE THAT EXPOSURE TO THE AIR CAN AFFECT THE TEST RESULT. I REITERATED THE CONDITIONS THAT CAN AFFECT TESTING. SHE STATES THAT THE BOTTLE IS NEVER LEFT OPEN. A STRIP IS REMOVED AND THE BOTTLE CLOSED. SHE SEEMS FAIRLY WELL INFORMED. SHE STATED THAT HE TAKES BLOOD PRESSURE MEDICATION, STEROIDS, INSULIN AND THYROID MEDS. SHE IS AWARE OF THE EFFECT OF STEROIDS ON HIS BLOOD GLUCOSE WHICH IS WHY THEY WATCH IT CLOSELY. THE TYPICAL BG RANGE FOR THIS CUSTOMER IS 150-200. THEY HAVE NO CONTROL SOLUTION SO WE ARE UNABLE TO TEST. STORAGE CONDITIONS ARE IN A BACK ROOM AWAY FROM HEAT SOURCES. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305935 GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 B4S1508007

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR