BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER & POWER SUPPLY

    MDR report key: 12632796 · Received October 14, 2021

    Report

    Report Number
    3002637618-2021-00060
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 14, 2021
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IN-HOUSE PERFORMANCE FOR THE CARD LOT IN QUESTION, 01-21201-50, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. THE INVESTIGATION FOCUSED ON THE IN-HOUSE EPOC PERFORMANCE FOR PO2. CARD LOT 01-21201-50 WAS TESTED WITH ARTERIALIZED BLOOD AND WITH AQUEOUS CONTROL FLUIDS EUROTROL L1 AND EUROTROL L3 AT THE TIME OF PRODUCT RELEASE. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD PERFORMED AS EXPECTED AND MET PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. IN ADDITION, THERE WERE NO OTHER COMPLAINTS RECEIVED ON CARD 01-21201-50. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. ADDITIONALLY, IT WAS NOTED THE CUSTOMER WAS USING EARLOBE CAPILLARY SAMPLES. THE PROCESS OF CAPILLARY COLLECTION MAY CHANGE PO2 LEVELS SIGNIFICANTLY AND IS SUSCEPTIBLE TO FACTORS SUCH AS AIR CONTAMINATION. ACCORDING TO CLSI C46-A BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS: APPROVED GUIDELINE, ARTERIAL BLOOD SAMPLES ARE PREFERRED FOR BLOOD GAS ANALYSIS. NO COMPARATIVE VALUE WAS OBTAINED AFTER THE PATIENT RECEIVED OXYGEN. WITHOUT A TRUE VALUE, THERE IS NOT ENOUGH INFORMATION TO ALLEGE THE EPOC WAS NOT PERFORMING AS IT WAS INTENDED. PATIENTS WITH LOW OXYGEN SATURATION MAY ENCOUNTER INCREASED OXYGEN EXTRACTION, WHICH COULD PRESENT AS A LOWER VENOUS OR CAPILLARY SAMPLE THAN EXPECTED. ADDITIONALLY, NO COMPARATIVE VALUE WAS OBTAINED FOR THE PO2 RESULT PRIOR TO RECEIVING OXYGEN SO IT IS NOT POSSIBLE TO DETERMINE IF THAT RESULT WAS CORRECT GIVEN THE SAMPLE TYPE USED. THERE IS NOT ENOUGH EVIDENCE THAT POINTS TO A SYSTEMIC PRODUCT PROBLEM AND THERE ARE MANY VARIABLES INTRODUCED WHEN CAPILLARY BLOOD IS USED FOR BLOOD GAS ANALYSIS. IT SHOULD ALSO BE NOTED THAT THE CUSTOMER'S QC WAS OUT OF RANGE PRIOR TO PATIENT ANALYSIS. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT LOW PO2 RESULTS FOR ONE PATIENT ON THE EPOC READER AFTER RECEIVING TWO LITERS OF OXYGEN FOR 15 MINUTES. THE SAMPLES WERE TAKEN FROM THE EARLODE USING A CAPILLARY TUBE. IT SHOULD BE NOTED THAT THE CUSTOMER'S QC WAS OUT OF RANGE LOW PRIOR TO PATIENT ANALYSIS. THE CUSTOMER STATED THE PHYSICIAN EXPECTED A RESULT ABOVE 60 MMHG. DUE TO LIMITED INFORMATION IN ADDITION TO THE FACT THAT NO COMPARATIVE VALUE WAS OBTAINED AFTER THE PATIENT RECEIVED OXYGEN, THIS COMPLAINT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528634 EPOC READER & POWER SUPPLY EPOC READER CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1