BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 2577055 · Received May 16, 2012

    Report

    Report Number
    9610806-2012-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    June 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY DEPRESSED PTT INR RESULT REPORTING WAS THE NATURE OF THE PATIENT SAMPLE. THE SAMPLE LIPEMIA CAUSED THE PRINTOUT OF AN ANALYSIS ERROR FLAG FOR SAMPLE TURBIDITY WITH THE RESULT. THE FLAG SHOULD HAVE PRECLUDED REPORTING WITHOUT FURTHER INVESTIGATION. THE OPERATOR FAILED TO FOLLOW INSTRUMENT MANUFACTURER'S INSTRUCTIONS IN THE OPERATOR'S GUIDE TO TROUBLESHOOT RESULTS PRIOR TO REPORTING. THE CA-7000 INSTRUMENT OPERATORS MANUAL READS: "RE-ANALYSIS IS REQUIRED FOR THE PARAMETER WHOSE ANALYSIS IS INTERRUPTED DUE TO AN INSTRUMENT ERROR AND FOR THE PARAMETER THAT GENERATED AN ANALYSIS ERROR." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED PTT CLOTTING TIME RESULT WAS REPORTED ON A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AT AN ALTERNATE FACILITY AND A PROLONGED RESULT WAS OBTAINED AND A CORRECTED RESULT REPORTED. THE PATIENT WAS TREATED ON THE BASIS OF THE INITIALLY DEPRESSED RESULT: THE PATIENT'S HEPARIN DOSAGE WAS INCREASED. THE HEPARIN DOSAGE WAS RE-ADJUSTED ON THE BASIS OF THE CORRECTED REPORT. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY DEPRESSED RESULT AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 547309

    Patients

    Seq Age Sex Outcome Treatment
    1