BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC THROMBIN REAGENT

    MDR report key: 6839175 · Received September 1, 2017

    Report

    Report Number
    9610806-2017-00095
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    November 29, 2016
    Report Date
    November 1, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJA
    PMA / PMN Number
    K970645
    Removal / Correction Number
    9610806-10/18/2017-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR ON SEPTEMBER 1, 2017. ADDITIONAL INFORMATION (SEPTEMBER 4, 2017): THE CUSTOMER USED TWO BC THROMBIN REAGENT KITS THAT CONTAIN THE BC THROMBIN REAGENT LOT NUMBER OF THE INITIAL MDR. THESE BC THROMBIN KITS HAVE LOT NUMBERS 46348 AND 46018 AND BOTH KITS EXPIRE ON FEBRUARY 25, 2018. THE DI NUMBER FOR THESE BC THROMBIN KITS IS (B)(4).

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) IS INVESTIGATING THE CAUSE OF THE VARIABILITY IN THROMBIN TIME (TT) RESULTS BETWEEN DIFFERENT REAGENT AND CONTROL LOTS. THE BCS XP SYSTEM REFERENCE GUIDE STATES 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." DIFFERENCES IN SECONDS FOR NORMAL PATIENT RESULTS DUE TO THE DEPENDENCY ON THE REAGENT LOT USED POTENTIALLY CONTRIBUTED TO THE VARIABILITY IN TT RESULTS. THE BC THROMBIN REAGENT LOT NUMBER IS PROVIDED AS THE BC THROMBIN KIT LOT NUMBER, CATALOG NUMBER, DI AND EXPIRATION DATE WERE NOT AVAILABLE AT THE TIME OF FILING. MDR 9610806-2017-00094 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00095 ON SEPTEMBER 1, 2017 AND THE SUPPLEMENTAL MDR 9610806-2017-00095_S1 ON SEPTEMBER 29, 2017. ADDITIONAL INFORMATION (OCTOBER 5, 2017): 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. UPDATED TO REFLECT THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER RAN PATIENT SAMPLES USING BC THROMBIN LOT 517467 ON THE BCS XP SYSTEM WHEN THE ALLOWABLE TOTAL ERROR (TEA) FOR INTERNAL QUALITY CONTROLS EXCEEDED THE LABORATORY'S SPECIFICATION OF 10%. THE INTERNAL QUALITY CONTROLS WERE WITHIN THE RANGE OF THE TABLES OF ASSIGNED VALUES (TAV). THE CUSTOMER INDICATED THE AVERAGE THROMBIN TIME RESULTS FOR NORMAL PATIENTS OBTAINED WITH LOT 517467 WERE LOW COMPARED TO LOT 517468. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA FOR EVALUATION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE TT RESULTS OBTAINED ON PATIENT SAMPLES WHEN THE TEA FOR INTERNAL QUALITY CONTROLS EXCEEDED THE LABORATORY'S SPECIFICATIONS OF 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619564 BC THROMBIN REAGENT BC THROMBIN REAGENT GJA SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BC THROMBIN REAGENT 517467

    Patients

    Seq Age Sex Outcome Treatment
    1