BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBOREL S

    MDR report key: 7110840 · Received December 12, 2017

    Report

    Report Number
    9610806-2017-00147
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 17, 2017
    Report Date
    February 2, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K003870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00147 ON 12-DEC-2017. ADDITIONAL INFORMATION (16-JAN-2018): THE UNIQUE IDENTIFIER NUMBER (UDI) FOR THE THROMBOREL S REAGENT IS (B)(4) WAS UPDATED TO REFLECT THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) INVESTIGATED THE CAUSE OF THE DISCORDANT PROTHROMBIN TIME (PT) RESULT, PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT AND PT% RESULT THAT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-5100 SYSTEM USING THE THROMBOREL S REAGENT. SIEMENS DETERMINED THAT A PRE-ANALYTICAL ISSUE (SPECIFIC SAMPLE CHARACTERISTICS, BLOOD COLLECTION, TRANSPORTATION, SAMPLE PROCESSING/HANDLING IN THE LABORATORY) POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULTS. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEMS AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE SYSTEMS OR REAGENTS IS REQUIRED. THE UNIQUE IDENTIFIER NUMBER (UDI) FOR THE THROMBOREL S REAGENT WAS NOT AVAILABLE AT THE TIME OF FILING THIS MDR. MDR 9610806-2017-00146 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS TESTED FOR PROTHROMBIN TIME (PT), PT INTERNATIONAL NORMALIZED RATIO (INR) AND PT % MULTIPLE TIMES USING 2 SYSMEX CS-5100 SYSTEMS. INITIALLY, ELEVATED PROTHROMBIN TIME (PT) RESULTS, ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AND LOW PT % RESULTS WERE OBTAINED ON THE SAMPLE, INDEPENDENT OF THE REAGENT OR SYSTEM USED TO RUN THE SAMPLE. WITH RESPECT TO THE REAGENT USED TO RUN THE SAMPLE, EACH TIME THE SAMPLE WAS RERUN, LOWER PT AND PT INR RESULTS AND HIGHER PT % RESULTS WERE OBTAINED. A RESULT WAS PROVIDED TO THE PHYSICIAN BUT IT IS UNKNOWN WHICH RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT PT RESULTS, PT INR RESULTS, AND PT % RESULTS OBTAINED ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889509 THROMBOREL S THROMBOREL S GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL S 546972

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR