BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC THROMBIN REAGENT

    MDR report key: 6995311 · Received November 1, 2017

    Report

    Report Number
    9610806-2017-00128
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    August 4, 2017
    Report Date
    November 1, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJA
    UDI-DI
    00842768013102
    PMA / PMN Number
    K970645
    Removal / Correction Number
    9610806-10/18/2017-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT THE BC THROMBIN REAGENT KIT LOT 46751 (CONTAINS THROMBIN REAGENT LOT 517468) AND KIT LOT 47184 (CONTAINS THROMBIN REAGENT LOT 517469) PRODUCE UNEXPECTED PROLONGED THROMBIN TIME (TT) RESULTS FOR EXPECTED NORMAL SAMPLES, AND MAY RECOVER ABOVE THE UPPER LIMIT OF NORMAL (< 21 SECONDS) AS STATED WITHIN THE IFU (INSTRUCTION FOR USE). THE INVESTIGATION BY SIEMENS CONFIRMED THAT THE REFERENCE RANGE IS SHIFTED TO AN APPROXIMATELY 20% PROLONGED TT. IF THE REFERENCE RANGE IS NOT ADJUSTED FOR THE CURRENT AFFECTED LOT, THIS MAY LEAD TO A HIGHER NUMBER OF SAMPLES REQUIRING FOLLOW-UP IN THE CASE OF SLIGHTLY PROLONGED TT. THERE IS A POTENTIAL FOR MISINTERPRETING UNEXPECTED PROLONGED RESULTS AS UNFRACTIONATED (UF) HEPARIN CONTAMINATION AND SOME OTHER THROMBIN INHIBITORS. AN URGENT FIELD SAFETY NOTICE (UFSN) PH-17-018.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS AND AN URGENT MEDICAL DEVICE CORRECTION (UMDC) PH17-018.A.US WAS SENT TO US CUSTOMERS IN OCTOBER 2017. THE UFSN AND UMDC REMIND CUSTOMERS THAT REFERENCE INTERVALS VARY FROM LABORATORY TO LABORATORY DEPENDING ON THE POPULATION, THE TECHNIQUE AND REAGENT LOT. THEREFORE, EACH LABORATORY MUST ESTABLISH ITS OWN REFERENCE INTERVALS OR VERIFY THEM WHENEVER ONE OR MORE OF THE AFOREMENTIONED VARIABLES ARE CHANGED. THE UFSN AND UDMC ALSO INFORMS CUSTOMERS USING THE BC THROMBIN REAGENT AS A SCREENING ASSAY FOR THROMBIN INHIBITION THAT THE AFFECTED LOTS ARE MORE SENSITIVE WITH APPROXIMATELY 20% PROLONGED/ELEVATED TT RESULTS. THIS WILL LEAD TO AN INCREASED RATE OF RESULTS ABOVE THE REFERENCE RANGE IF NOT ADJUSTED. THUS, THE UFSN AND UDMC ADVISE CUSTOMERS TO ADJUST THEIR SPECIFIC REFERENCE RANGES AS PER THE APPLICATION SHEET FOR THROMBIN TIME WITH BC THROMBIN WHEN CHANGING TO A NEW LOT. MDR 9610806-2017-00129 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A SIEMENS' DISTRIBUTOR REPORTED THAT ONE OF THEIR CUSTOMERS ((B)(6)) REJECTED THE USE OF BC THROMBIN REAGENT LOT 517468 (KIT LOT # 46751) AFTER THEY PERFORMED A CORRELATION STUDY ON PATIENT SAMPLES BETWEEN THEIR PREVIOUS BC THROMBIN REAGENT LOT 517467 AND LOT 517468 ON A BCS XP SYSTEM. THEY OBSERVED AN INCREASE IN THROMBIN TIME (TT) RECOVERY ON PATIENT SAMPLE RESULTS AND WHEN THEY RAN INTERNAL QUALITY CONTROL (QC) (CONTROL PLASMA N), THEY REPORTED HIGH QC RECOVERY. THE DISTRIBUTOR INDICATED THAT CONTROL PLASMA NORMAL LOT 507734 AND 507740 WERE RUN USING BC THROMBIN REAGENT LOT 517469 (KIT LOT # 47184) AND THE QUALITY CONTROLS RECOVERED WITHIN RANGE AND NORMAL PATIENT RESULTS RECOVERED WITHIN THE REFERENCE RANGE FOR THROMBIN TIME. THE DISTRIBUTOR INDICATED THAT (B)(6) WILL START USING BC THROMBIN REAGENT LOT 517469. IT IS UNKNOWN IF THE CUSTOMER IS REPORTING RESULTS USING LOT 517469. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH QC AND PATIENT SAMPLE RECOVERY ON THE BCS XP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773134 BC THROMBIN REAGENT BC THROMBIN REAGENT GJA SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BC THROMBIN REAGENT 47184 00842768013102

    Patients

    Seq Age Sex Outcome Treatment
    1