BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL LABORATORY AUTOMATION

    MDR report key: 38143 · Received September 5, 1996

    Report

    Report Number
    38143
    Event Type
    Injury
    Date Received
    September 5, 1996
    Date of Event
    June 7, 1996
    Report Date
    August 14, 1996
    Manufacturer
    MEDICAL LABORATORY AUTOMATION
    Product Code
    KQG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB EVALUATION SHOWED PRO-TIME GREATER THAN 100 SECS, FIBRINOGEN 436, PLATELET COUNT 227, AND 3+ SERUM PROTEIN. DIAGNOSIS OF COAGULOPATHY MADE WITH MEDICAL TREATMENT INCLUDING VITAMIN K, TRANSFUSION WITH FOUR UNITS OF FRESH FROZEN PLASMA. LABOR WAS INDUCED. DELIVERY OF VIABLE INFANT. PROTIME CONTINUED AT GREATER THAN 100 SECS. ADD'L MEDICAL INTERVENTION INCLUDED VITAMIN K, 8 UNITS OF FRESH FROZEN PLASMA. PT DEVELOPED SYMPTOMS OF PULMONARY EDEMA. MEDICAL TREATMENT WITH LASIX, DECREASED FLUIDS. PRO-TIME SENT TO REF LAB WITH RESULTS OF 7.4 SECS. PT RECOVERY WITH HOME DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL LABORATORY AUTOMATION COAGULATION ANALYZER KQG MEDICAL LABORATORY AUTOMATION MLA ELECTRA 1000C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention