BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6464856 · Received April 6, 2017

    Report

    Report Number
    9610806-2017-00048
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 14, 2017
    Report Date
    April 14, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE DISCORDANT HIGH PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR) PATIENT RESULT THAT WAS GENERATED ON THE CS-5100 ANALYZER.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (9610806-2017-00048) ON APRIL 6, 2017. APRIL 7, 2017 - CORRECTED INFORMATION: THIS MDR (9610806-2017-00048) WAS A DUPLICATE OF MDR 9610806-2017-00042 WHICH WAS FILED ON MARCH 28, 2017.

    Description of Event or Problem · 1

    A DISCORDANT HIGH PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR) PATIENT RESULT WAS GENERATED ON THE CS-5100 ANALYZER. ALL QC RECOVERY WAS ACCEPTABLE. THE INITIAL PT/INR PATIENT RESULT GENERATED A PT OF 134.8 SECONDS / INR (CALCULATED) 12.37 (WITH 0000.0000.1100 "VIAL QC HAS NOT PERFORMED" FLAG). THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RE-TESTED 3 TIMES (REPEATS 1-3) ON A DIFFERENT SYSTEM (CS-5100) AND GENERATED: (B)(6). THE REPEAT RESULTS CORRESPONDED TO THE MEDICAL CONDITION OF THE PATIENT. ONLY THE RESULTS FROM REPEAT 3 WERE REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN IMPACT OR ADVERSE HEALTH CONSEQUENCE TO THE PATIENT DUE TO THE DISCORDANT HIGH PT / INR RESULT AS THE INITIAL PT / INR RESULT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247599 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539369

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR