BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC READER & POWER SUPPLY

    MDR report key: 12526222 · Received September 24, 2021

    Report

    Report Number
    3002637618-2021-00055
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 5, 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 · 0

    SIEMENS HAS EVALUATED THE CARD LOT PERFORMANCE: THE IN-HOUSE PERFORMANCE FOR THE CARD LOT IN QUESTION, 01-21177-50, WAS INVESTIGATED FOR PO2 PERFORMANCE AND DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. CARD LOT 01-21177-50 WAS TESTED WITH ARTERIALIZED BLOOD WITH A TARGET PO2 OF APPROXIMATELY 80 MMHG AND WITH AQUEOUS CONTROL FLUIDS EUROTROL L1 AND EUROTROL L3 AT THE TIME OF PRODUCT RELEASE. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD DISPLAYED NO INDICATION OF DISCREPANT RESULTS AT THE TIME OF RELEASE. THERE WERE NO OTHER COMPLAINTS RECEIVED ON CARD 01-21177-50. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. SIEMENS RECOMMENDS USING THE CORRECT REFERENCE RANGES ASSOCIATED WITH THE SAMPLE TYPE COLLECTED. ACCORDING TO THE DATA, ALL OF THE PO2 RESULTS WERE ACCEPTABLE RESULTS FOR THE EARLOBE CAPILLARY SAMPLE TYPE USED FOR ANALYSIS. ADDITIONALLY, THE CUSTOMER WAS USING EARLOBE CAPILLARY SAMPLES. ACCORDING TO CLSI C46-A BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS: APPROVED GUIDELINE, ARTERIAL BLOOD SAMPLES ARE PREFERRED FOR BLOOD GAS ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THEY DO NOT MEASURE QC FOR TESTING THE INSTRUMENT. SIEMENS HAS REQUESTED THE CSV AND T-FILES TO BE RETURNED FOR INVESTIGATION. THE CUSTOMER HAS RESPONDED THAT THEY ARE NOT AVAILABLE TO BE RETURNED. THE LOT # 01-21177-50 WILL BE REVIEWED FOR PO2 PERFORMANCE. THE CUSTOMER STATED THEY ARE OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT LOW PO2 RESULTS ON TWO PATIENTS ON THE EPOC READER WHICH DID NOT MEET EACH PATIENT'S CONDITION. THE CLINICIAN DID NOT DO REPEAT TESTING ON THE TWO PATIENTS. THE CUSTOMER STATED THE EXPECTED RESULT WAS TO BE APPROXIMATELY 80 MMHG. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423828 EPOC READER & POWER SUPPLY EPOC READER CGL EPOCAL INC. HR-1002-00-00 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1