BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERICHROM ANTITHROMBIN III

    MDR report key: 4484141 · Received February 4, 2015

    Report

    Report Number
    9610806-2015-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 8, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JPE
    PMA / PMN Number
    K933125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED ANTITHROMBIN III (ATIII) RESULTS IS USER ERROR. SIEMENS CUSTOMER CARE CENTER REPRESENTATIVES INVESTIGATION OF INSTRUMENT DATA HAS DETERMINED THE SEQUENCE OF EVENTS LEADING TO THE DISCREPANT ELEVATED RESULTS. THE CUSTOMER INDICATED IN THE COMPLAINT THAT THEY HAD RUN OUT OF THE THROMBIN REAGENT USED IN THE ATIII TEST AFTER THE INITIAL PROCESSING OF THE SAMPLES. REVIEW OF THE INSTRUMENT FILES INDICATED INSUFFICIENT REAGENT ERRORS WERE PRESENT PRIOR TO SAMPLE PROCESSING. THERE IS NO INDICATION OF INSTRUMENT MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED ANTITHROMBIN III RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES RUN ON THE BCS XP INSTRUMENT. A PATIENT RESULT WAS REPORTED TO THE PHYSICIAN FOR ONE OF THE SAMPLES. BOTH SAMPLES WERE REPEATED AFTER THE THROMBIN REAGENT USED WAS REPLENISHED. LOWER RESULTS WERE OBTAINED AND CORRECTED RESULT WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED ANTITHROMBIN III RESULTS. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY ELEVATED ANTITHROMBIN III RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79763 BERICHROM ANTITHROMBIN III BERICHROM ANTITHROMBIN III JPE SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 520286

    Patients

    Seq Age Sex Outcome Treatment
    1