BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT

    MDR report key: 6684264 · Received July 3, 2017

    Report

    Report Number
    9610806-2017-00069
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    June 6, 2017
    Report Date
    July 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GFO
    PMA / PMN Number
    K760318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) DETERMINED THAT THE CAUSE OF THE UNEXPECTED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WAS DUE TO THE OPERATOR'S USE OF THE INCORRECT REAGENT (ACTIN ACTIVATED CEPHALOPLASTIN). THE SYSMEX CA-1500 COAGULATION ANALYZER WAS SET UP FOR THE ACTIN FSL REAGENT DETECTOR AND THE OPERATOR MISTAKENLY USED THE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE OPERATOR HAS BEEN USING THE INCORRECT ACTIN ACTIVATED CEPHALOPLASTIN REAGENT SINCE (B)(6)2017 AND IT IS UNKNOWN WHEN THEY STARTED USING THE CORRECT ACTIN FSL REAGENT. BASED ON THE DATA PROVIDED BY THE OPERATOR, SIEMENS DETERMINED THAT THE OPERATOR PERFORMED A PARALLEL STUDY ON THE INTERNAL QUALITY CONTROL BETWEEN ACTIN ACTIVATED CEPHALOPLASTIN AND ACTIN FSL REAGENTS. THERE WAS A SIGNIFICANT DIFFERENCE OF APPROXIMATELY 25% IN THE INTERNAL QUALITY CONTROLS BETWEEN THE REAGENTS. INTERNAL QUALITY CONTROL LEVEL 1 RECOVERED WITHIN RANGE WHILE INTERNAL QUALITY CONTROL LEVEL 3 RECOVERED LOW WITH THE INCORRECT ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE ACTIN ACTIVATED CEPHALOPLASTIN (ACTIN) REAGENT IS LESS SENSITIVE TO HEPARIN, LUPUS AND FACTORS THAN THE ACTIN FSL REAGENT. RESULTS OBTAINED USING THE ACTIN REAGENT, IN THE HEPARIN THERAPEUTIC RANGE, ARE EXPECTED TO BE LOWER THAN THE RESULTS OBTAINED USING ACTIN FSL REAGENT. UNLESS A NEW REFERENCE INTERVAL IS ESTABLISHED, IT IS POSSIBLE THAT FUNCTIONAL FACTOR DEFECTS (VIII, IX, XI, XII) OR LUPUS ANTICOAGULANTS COULD BE MISSED. APTT IS NOT A CALIBRATED ASSAY AND IT IS REPORTED IN RAW SECONDS. CHANGE OF REAGENT LOT OR TYPE REQUIRES RE-ESTABLISHMENT OF NORMAL AND THERAPEUTIC RANGES TO ENSURE ACCURATE INTERPRETATION OF RESULTS. ACCORDING TO THE OPERATOR, THE WRONG REAGENT WAS USED TO RUN PATIENT SAMPLES. THE OPERATOR INDICATED THAT THEY SWITCHED BACK TO THE CORRECT REAGENT- ACTIN FSL REAGENT. THE OPERATOR STATED THAT ONE CORRECTED REPORT WAS ISSUED AND NO OTHER SAMPLES WERE QUESTIONED BY PHYSICIAN(S). MDR 9610806-2017-00066 WAS FILED FOR THE SAME EVENT. THE INSTRUMENT AND THE REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN UNEXPECTEDLY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF >300 SECONDS WAS OBTAINED ON A PATIENT SAMPLE (SPECIMEN (B)(6)) ON THE SYSMEX CA-1500 ANALYZER USING THE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE APTT RESULT OF >300 SECONDS WAS REPORTED TO THE PHYSICIAN. THE PATIENT BLOOD WAS RE-DRAWN AND RUN ON THE SAME SYSMEX CA-1500 ANALYZER USING THE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT AND AN UNEXPECTEDLY LOW APTT RESULT OF 55.3 SECONDS WAS OBTAINED. IT IS UNKNOWN WHETHER THE APTT RESULT OF 55.3 SECONDS WAS REPORTED TO THE PHYSICIAN. THE OPERATOR STATED THAT THERE WAS A USER ERROR SINCE THEY RAN PATIENT SAMPLES USING THE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT WHILE THE SYSMEX CA-1500 ANALYZER WAS SET UP FOR THE ACTIN FSL REAGENT DETECTOR. THE PATIENT BLOOD WAS RE-DRAWN THE NEXT DAY AND RUN ON THE SAME SYSMEX CA-1500 ANALYZER USING THE CORRECT ACTIN FSL REAGENT. AN APTT RESULT OF 85 SECONDS WAS OBTAINED. THE CORRECTED RESULT OF 85 SECONDS WAS REPORTED TO THE PHYSICIAN. THE OPERATOR'S APTT REFERENCE RANGE IS 21.8-31.5 SECONDS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE UNEXPECTED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464902 DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT 557231

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR