BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 3777273 · Received April 29, 2014

    Report

    Report Number
    9610806-2014-00018
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 1, 2014
    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 DISCREPANT ELEVATED ACTIVATED PARTIAL THROMOBOPLASTIN TIME RESULTS IS USER ERROR. THE ACCOUNT ENTERED THE INCORRECT U.S. SETTINGS CALIBRATION CURVE INPUT FOR THE ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WITH ACTIN FSL USING LOT 547378. THESE VALUES ARE MANUALLY INPUT BY THE OPERATOR. THE INCORRECT CURVE HAS BEEN IN USE SINCE MID-FEBRUARY. THE ISSUE WAS RESOLVED BY DIRECTING THE ACCOUNT TO USE A U.S. SETTINGS CALIBRATION CURVE WITH THE APPROPRIATE INPUT FOR THE APTT WITH ACTIN FSL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES. PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN DURING AN INTERVAL OF INCORRECT APTT PROTOCOL SETTINGS. THE QC SAMPLES WERE REPEATED WITH THE CORRECT PROTOCOL SETTINGS AND LOWER, WITHIN RANGE RESULTS WERE OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED DUE TO DISCREPANT APTT RESULTS REPORTED. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENTS AS A RESULT OF THE DISCREPANT APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257853 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 547378

    Patients

    Seq Age Sex Outcome Treatment
    1