BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER

    MDR report key: 10422654 · Received August 18, 2020

    Report

    Report Number
    3002637618-2020-00043
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    September 10, 2020
    Manufacturer
    EPOCAL INC.
    Product Code
    CGL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K113726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUESTED ENCRYPTED TEST RECORDS. A REVIEW OF THE IN-HOUSE PERFORMANCE FOR THE CARD LOT USED, LOT 01-20121-10, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE FAILURE RATE OF LOT 01-20121-10 IS NOT SHOWING AN INCREASED TREND IN THE FIELD, THEREFORE, THERE IS NO FURTHER EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. THE CUSTOMER HAS BEEN ADVISED THAT BLOOD GAS MEASUREMENTS FOR THE PURPOSE OF EVALUATING THE GAS EXCHANGE FUNCTION OF THE LUNGS (PO2 AND PCO2) SHOULD BE PERFORMED ON ARTERIAL BLOOD ONLY. FURTHERMORE, IN CASES WHERE "ARTERIALIZED" CAPILLARY BLOOD MAY BE THE ONLY PRACTICAL ALTERNATIVE TO ARTERIAL BLOOD, THE BLOOD GAS RESULTS SHOULD BE INTERPRETED CAUTIOUSLY.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS REQUESTED DATA FILES TO BE SENT FOR INVESTIGATION. THE CUSTOMER STATED THAT NO INSTRUMENT DATA IS AVAILABLE. SIEMENS THEN ASKED IF THE ENCRYPTED TEST RECORDS COULD BE EXTRACTED? INSTRUCTIONS HAVE BEEN SENT TO THE CUSTOMER. THESE ARE RESULT FILES THAT REMAIN ON THE HOST AND DOES NOT CROSS OVER TO THE DATA MANAGER. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT PO2 RESULTS ON TWO PATIENTS WHEN TESTED ON THE EPOC READER S/N (B)(4). THE PATIENTS WERE FIRST ANALYZED WITHOUT OXYGEN SUPPLY. THEN THE PATIENTS WERE GIVEN 2L OF OXYGEN FOR 15 MINUTES. THEN THE PATIENTS WERE TESTED AGAIN. THE PHYSICIAN FELT THE RESULTS WERE TOO HIGH AFTER OXYGEN THERAPY DUE TO KNOWING THE PATIENTS HISTORIES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883943 EPOC READER EPOC READER CGL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1