BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIBRIN U

    MDR report key: 4856067 · Received June 19, 2015

    Report

    Report Number
    9610806-2015-00013
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 26, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    KQJ
    PMA / PMN Number
    K934326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT FALSELY DEPRESSED FIBRINOGEN RESULT IS A KNOWN SUSCEPTIBILITY OF THE MULTIFIBRIN U REAGENT. THE FALSELY DEPRESSED LEVEL APPEARS TO BE RELATED TO THE PATIENT'S MEDICATION. THE SAMPLE RESULT WAS ACCOMPANIED BY THE COMMENT "RESULTS DOUBTFUL" AND THE ANALYZER OPERATED AS INTENDED. PER THE BCS XP OPERATOR'S GUIDE THIS COMMENT FLAG DOES NOT PRECLUDE RESULT REPORTING BUT WOULD ALERT THE OPERATOR TO INVESTIGATE FURTHER. THE PATIENT IS ON ARGATROBAN THERAPY, WHICH CAN LEAD TO FALSELY DEPRESSED FIBRINOGEN LEVELS. ARGATROBAN IS A DIRECT THROMBIN INHIBITOR. MULTIFIBRIN U REAGENT CONTAINS BOVINE THROMBIN. THE PRINCIPLE OF THE FIBRINOGEN WITH MFU ASSAY IS " CITRATED PLASMA IS BROUGHT TO COAGULATION BY A LARGE EXCESS OF THROMBIN." INCORPORATING A MEDICATION THAT IS INTENDED TO INHIBIT THE FUNCTION OF THROMBIN CAN LEAD TO INTERFERENCE IN THESE ASSAYS. DOCUMENTED IN THE MULTIFIBRIN U INSTRUCTIONS FOR USE, LIMITATIONS OF THE PROCEDURE SECTION IS THE STATEMENT: "THERAPY WITH DIRECT THROMBIN INHIBITORS, E.G. HIRUDIN, MAY CONTRIBUTE TO DIMINISHED RECOVERY." THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED, FLAGGED FIBRINOGEN RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE DEPRESSED, FLAGGED PATIENT RESULT WAS REPORTED TO THE PHYSICIANS WHO EVENTUALLY QUESTIONED THE RESULT. THE REPEAT TEST OF THE SAMPLE PROVIDED A HIGHER RESULT IN THE NORMAL REFERENCE RANGE. PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED FIBRINOGEN RESULT. FRESH FROZEN PLASMA AND CRYOPRECIPITATE WERE ADMINISTERED BEFORE THE PHYSICIAN QUESTIONED THE RESULT. THE PATIENT EXPERIENCED A THROMBOTIC EVENT. THEY PATIENT WAS FURTHER TREATED TO REVERSE THE EFFECTS OF THE CRYOPRECIPITATE TREATMENT. THE ACCOUNT HAS NOTED THAT THE PATIENT IS OK AFTER THAT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399030 MULTIFIBRIN U MULTIFIBRIN U KQJ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other