BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

    MDR report key: 2543506 · Received April 20, 2012

    Report

    Report Number
    1832816-2012-00033
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    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. 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 EXPRESSION METER WAS GIVING HIGH READINGS. MR. (B)(6)'S SON CALLED IN ON HIS BEHALF STATING THAT HIS FATHER TESTED AND THE RESULTS WERE HIGH, SO HE TOOK HIS INSULIN AND THEN RETESTED ABOUT 20 MINUTES LATER HE RETESTED AND THE RESULT INDICATED THAT HIS BG LEVEL WAS HIGHER THEN IT ORIGINALLY WAS. CALLER WHEN TO THE PHARMACIST WHO TOLD HIM TO CHECK THE METER WITH THE CONTROL SOL. WHEN HE DID THE CONTROLS WERE OUT OF RANGE, BUT HE DIDN'T HAVE THE METER IN CONTROL MODE. THEN HE PERFORMED A TEST IN CONTROL MODE WITH THE CONTROL SOLUTIONS ON HIS FINGER AND THE READINGS WERE ALSO OUT OF RANGE 133 (RANGE 96-130). HE WAS USING INCORRECT TECHNIQUE TO TEST CONTROLS. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW APEX BIOTECHNOLOGY CORP. 571100 TQS500H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening