BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FS ACTIVATED PTT REAGENT

    MDR report key: 6508230 · Received April 20, 2017

    Report

    Report Number
    9610806-2017-00051
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 20, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    PMA / PMN Number
    K811589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE DISCORDANT, ELEVATED PROTHROMBIN TIME (PT) AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT ON THE SYSMEX CS-5100 SYSTEM AND FOUND THAT THERE WERE NO ISSUES WITH THE SYSTEM BEFORE OR AFTER PROCESSING THIS PATIENT'S SAMPLE. FURTHER INVESTIGATION FOR THIS PATIENT SAMPLE IS NOT POSSIBLE BECAUSE THE CUSTOMER'S BACK UP DOES NOT CONTAIN LOG AND RESULT FILES FROM THE INCIDENT DATE (03/28/2017) . IT IS POSSIBLE THAT THE DISCORDANT RESULTS WERE DUE TO THE FACT THE CUSTOMER SET "STANDARD SAMPLE TUBE" ON ALL THREE SYSTEMS DESPITE USING THREE DIFFERENT TYPES OF TUBES FROM BECTON DICKINSON. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE OTHER ASSAY THAT PROVIDED DISCORDANT RESULT IN THIS INCIDENT IS THROMBOREL S. THE DETAILS FOR THIS ASSAY IS LISTED BELOW: COMMON DEVICE NAME: THROMBOREL S. MODEL NUMBER: THROMBOREL S. CATALOG NUMBER: 10446445. LOT NUMBER: 546971. EXPIRATION DATE (MM/DD/YYYY): 09/12/2018. (B)(4).

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND A DISCORDANT, FALSELY HIGH PROTHROMBIN TIME (PT) RESULT WERE OBTAINED ON A PATIENT'S SAMPLE ON THE SYSMEX CS-5100 INSTRUMENT. THESE RESULTS WERE NOT PROVIDED TO THE PHYSICIAN. THE SAME PATIENT'S BLOOD SAMPLE WAS RE-RUN ON ANOTHER SYSMEX CS-5100 SYSTEM. THE RESULTS OBTAINED FROM THE REPEAT TESTING ALIGNED WITHIN THE PATIENT'S MEDICAL HISTORY. THE RE-RUN RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT AND PT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290150 DADE ACTIN FS ACTIVATED PTT REAGENT DADE ACTIN FS ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FS ACTIVATED PTT REAGENT 538521A

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR