BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIBRIN U

    MDR report key: 916291 · Received September 18, 2007

    Report

    Report Number
    9610806-2007-00011
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 24, 2007
    Report Date
    August 29, 2007
    Manufacturer
    DADE BEHRING GMBH
    Product Code
    KQJ
    PMA / PMN Number
    K934326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE HOSPITAL PATHOLOGIST CONCLUDED THAT THE CAUSE FOR THE FALSELY DEPRESSED FIBRINOGEN WAS INTERFERENCE FROM THE PATIENT'S MULTIPLE MYELOMA PROTEINS.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED FIBRINOGEN RESULT OF LESS THAN OR EQUAL TO 50 MG/DL WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TREATED WITH 2 UNITS OF CRYOPRECIPITATE. ANOTHER SAMPLE WAS TESTED POST TREATMENT AND A RESULT OF LESS THAN OR EQUAL TO 50 MG/DL WAS OBTAINED. THE SAME SAMPLE WAS REPEATED BY ALTERNATE METHODOLOGY AND A RESULT OF 545 MG/DL WAS OBTAINED. THE PATIENT WAS TREATED WITH 2 UNITS OF CRYOPRECIPITATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE TREATMENT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE HOSPITAL PATHOLOGIST CONCLUDED THAT THE CAUSE FOR THE FALSELY DEPRESSED FIBRINOGEN WAS INTERFERENCE FROM THE PATIENT'S MULTIPLE MYELOMA PROTEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIBRIN U FIBRINOGEN REAGENT KQJ DADE BEHRING GMBH NA 519829

    Patients

    Seq Age Sex Outcome Treatment
    1 YR