BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBOREL S REAGENT

    MDR report key: 7207699 · Received January 19, 2018

    Report

    Report Number
    9610806-2018-00014
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 29, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    UDI-DI
    00842768011337
    PMA / PMN Number
    K003870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR 9610806-2018-00014 ON 19-JAN-2018. 24-JAN-2018 ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS REVIEWED INFORMATION PROVIDED BY THE CUSTOMER REGARDING THE DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)) AND COULD NOT IDENTIFY AN ISSUE WITH INSTRUMENT PERFORMANCE. THE CAUSE OF THE ISSUE OBSERVED COULD BE LIMITED TO A PRE-ANALYTICAL ISSUE INVOLVING INSUFFICIENT SAMPLE MIXING. 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. MDR 9610806-2018-00013_S1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE THAT WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). MDR 9610806-2018-00013 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN AS THEY DID NOT MEET THE CLINICAL HISTORY OF THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A DIFFERENT SYSMEX CS-5100 (SN (B)(4)) AND LOWER APTT, PT, INR, AND DER FIB PATIENT RESULTS WERE GENERATED. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. ALL RESULTS WERE RUN ON THE SAME DAY ((B)(6) 2017) ON THE SAME PATIENT SAMPLE. THE PT /INR /DER FIB PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THROMBOREL S REAGENT AND APTT PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THE DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME (PTT) REAGENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH APTT, PT, INR, AND DER FIB PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50892 THROMBOREL S REAGENT THROMBOREL S REAGENT GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 546971 00842768011337

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR