BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPOC BGE TEST CARD

    MDR report key: 2601881 · Received November 5, 2009

    Report

    Report Number
    3004959793-2009-00001
    Event Type
    Other
    Date Received
    November 5, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 6, 2009
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD USE: DATA COLLECTED BY THE EPOC SYSTEM AT THE TIME OF ANALYSIS WAS ANALYZED. THERE IS EVIDENCE TO SUPPORT THAT STORAGE SPECIFICATIONS WERE EXCEEDED FOR THESE EPOC BGE TEST CARDS. DATA INDICATES STORAGE TEMPERATURES EXCEEDED 30 DEGREES C FOR A PROLONGED PERIOD OF TIME. MORE SPECIFICALLY, LOT 00431-00 WAS STORED AT AN AVERAGE TEMPERATURE OF 38.5 DEGREES C. STORAGE OF THESE CARDS AT ELEVATED TEMPERATURES HAS CAUSED EXPEDITED AGING OF THE REFERENCE ELECTRODE AND CAUSED THE PH CAL MEAN TO BE FAR LOWER THAN THAT OF CARDS STORED PROPERLY. PRODUCT LABELING SUPPORTS EPOC TEST CARD STORAGE AT 15 TO 30 DEGREES C.

    Description of Event or Problem · 1

    A PH RESULT OF 7.277 WAS OBTAINED FROM THE EPOC SYSTEM ON A WHOLE BLOOD SAMPLE. THE PT'S PHYSICIAN ADMINISTERED SODIUM BICARBONATE BASED ON THE PH RESULTS WHICH WERE CONSIDERED ABNORMAL (LOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOC BGE TEST CARD CHL, CEM, JFP, JPI, JGS CHL EPOCAL INC. EPOC BGE 00431-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other