BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBRINTIMER A COAGULATION ANALYZER

    MDR report key: 31607 · Received March 28, 1996

    Report

    Report Number
    MW1008750
    Event Type
    Malfunction
    Date Received
    March 28, 1996
    Date of Event
    February 22, 1996
    Report Date
    March 7, 1996
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR ACUTE APPENDICITIS 2/22/96. PRE-SURGICAL LABWORK WAS ORDERED AT 14:43. THE SECOND SHIFT HAD JUST STARTED AND THE TECHNOLOGIST HAD JUST RUN QC ON THE DEVICE. ALL QC WAS WITHIN LIMITS. SHE THEN RAN THE PT AND APTT ON PT. THE APTT RESULTS WERE MARKEDLY ELEVATED AT 60 SEC. SHE REMADE CONTROLS AND REAGENTS AND REPEATED THE QC. THE QC WAS AGAIN WITHIN LIMITS. THE LABWORK WAS THEN REPEATED. RESULTS WERE STILL ELEVATED AT 40 SEC FOR THE APTT. BY THIS TIME THE PT WAS IN THE SURGERY HOLDING AREA. A REPEAT PT AND APTT WERE ORDERED ALONG WITH AN IVY. BLEEDING TIME AND FIBRINOGEN AT 16:31. SEE RESULTS BELOW. THE SURGERY WAS POSTPONED DUE TO ELEVATED RESULTS AND THE PT WAS TRANSFERRED TO ANOTHER MEDICAL CENTER. THE SAME TESTS WERE REPEATED AT THE OTHER MEDICAL CENTER. ALL RESULTS WERE NORMAL PER THE ATTENDING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBRINTIMER A COAGULATION ANALYZER COAGULATION ANALYZER JPA BEHRING DIAGNOSTICS, INC. FIBRINTIMER A

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR