BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 2966262 · Received February 18, 2013

    Report

    Report Number
    9610806-2013-00004
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DISCREPANT ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS IS UNKNOWN. A CONTRIBUTOR TO AT LEAST ONE OF THE ELEVATED RESULTS WAS USER ERROR. ONE SAMPLE WAS DRAW FROM A LINE WITH HEPARIN IN THE LINE. THE PATTERN OF DISCREPANT RESULTS IS STRONGLY SUGGESTIVE OF PATIENT SAMPLE SPECIFIC FACTORS. THE INSTRUMENT AND SOFTWARE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCREPANT ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) CLOTTING TIME RESULT WAS REPORTED ON A PATIENT SAMPLE. THE SAME SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. THE PATIENT WAS TREATED ON THE BASIS OF THE ELEVATED APTT RESULT. THE PATIENT WAS ADMINISTERED FRESH FROZEN PLASMA AND CRYOPRECIPITATES. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE DISCREPANT ELEVATED APTT RESULT AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70882 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 547339

    Patients

    Seq Age Sex Outcome Treatment
    1