BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6681997 · Received June 30, 2017

    Report

    Report Number
    9610806-2017-00068
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 20, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    UDI-DI
    00842768003783
    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. FILED THE INITIAL MDR 9610806-2017-00068 ON JUNE 30, 2017. JULY 7, 2017 ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS REVIEWED BACKUP AND LOG FILES PROVIDED BY THE CUSTOMER AND CONCLUDED THAT THE CS-5100 ANALYZER IN THE LABORATORY AS WELL AS THE REAGENT (PT INNOVIN) ARE PERFORMING AS EXPECTED. THE ROOT CAUSE FOR THE ISSUE OBSERVED COULD BE LIMITED TO A PRE-ANALYTICAL ISSUE (SPECIFIC SAMPLE CHARACTERISTICS, BLOOD COLLECTION, TRANSPORTATION, SAMPLE PROCESSING/HANDLING IN THE LABORATORY). NO PRODUCT NON-CONFORMANCE COULD BE IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. METHOD CODE, RESULT CODE AND CONCLUSION CODE WERE UPDATED TO REFLECT THE RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISCORDANT HIGH PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR) EXTENDED RESULTS ON ONE PATIENT SAMPLE WERE GENERATED ON THE CS-5100 ANALYZER USING THE INNOVIN PT ASSAY VERSUS THE THROMBOREL S PT ASSAY. THE THOMBOREL S PT / INR RESULTS WERE IN LINE WITH THE CLINICAL HISTORY OF THE PATIENT. THE SAME SAMPLE AND SYSTEM WERE USED FOR TESTING WITH BOTH ASSAYS. ALL QC RECOVERY WAS ACCEPTABLE. THE INNOVIN PT / INR PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN IMPACT OR ADVERSE HEALTH CONSEQUENCE TO THE PATIENT DUE TO THE DISCORDANT HIGH INNOVIN PT / INR RESULTS GENERATED ON THE ONE PATIENT SAMPLE AS THOSE RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462784 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539391 00842768003783

    Patients

    Seq Age Sex Outcome Treatment
    1