BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FS ACTIVATED PTT REAGENT

    MDR report key: 6947322 · Received October 13, 2017

    Report

    Report Number
    9610806-2017-00115
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 13, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    PMA / PMN Number
    K811589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST ANALYZED ONE OF THE BCS XP SYSTEM (SERIAL (B)(4)) BACKUP FILES TO DETERMINE THE CAUSE OF THE DISCORDANT LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS. THE HSC SPECIALIST DETERMINED THAT THE REAGENT VIAL USED TO OBTAIN THE APTT RESULTS ON THESE PATIENT SAMPLES WAS USED FOR PREVIOUS PATIENT SAMPLES AND THAT THERE WERE NO ISSUES WITH INTERNAL QUALITY CONTROLS AND OTHER SAMPLES. THE HSC SPECIALIST DETERMINED THAT THE KINETICS OF THE COAGULATION REACTIONS WERE UNEXPECTED FOR THE APTT ASSAY AND DETERMINED THAT THE FLAGS WERE PLAUSIBLE SINCE THE KINETICS SHOW VERY HIGH ABSORBANCE. THE HIGH ABSORBANCE CONFIRMED THAT THE AFFECTED SAMPLES WERE LIPEMIC. THE LIPEMIC SAMPLES AND OTHER SAMPLE SPECIFIC ISSUES POTENTIALLY CONTRIBUTED TO THE UNEXPECTED REACTION CURVES AND THE DISCORDANT RESULTS. THERE IS NO INDICATION OF EITHER A SYSTEMIC OR REAGENT PERFORMANCE ISSUE AT THE TIME OF THE EVENT. THE BACKUP FILES OF THE BCS XP SYSTEM (SERIAL (B)(4)) WERE NOT AVAILABLE AT THE TIME OF REPORTING THIS INCIDENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW APTT RESULTS IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE REAGENT IS REQUIRED. THE RILIBÄK COMPLIANT DADE ACTIN FS ACTIVATED PTT REAGENT WITH CATALOG NUMBER 10284498 DESCRIBED IN MODEL #/LOT # IS NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER IS FOR THE US SPECIFIC REAGENTS. THE DADE ACTIN FS ACTIVATED PTT REAGENT LOTS MARKETED IN THE US HAVE CATALOG NUMBERS 10445712 AND 10445710.

    Description of Event or Problem · 1

    A FLAGGED, DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A LIPEMIC PATIENT SAMPLE ON THE BCS XP SYSTEM. THE SAME PATIENT SAMPLE WAS RUN USING THE BACKUP ASSAY AT 570 NM ON THE SAME SYSTEM, RESULTING LOWER. THE CUSTOMER VALIDATED THE RESULT ON THE LABORATORY INFORMATION SYSTEM (LIS) AND RELEASED THE RESULT TO THE EMERGENCY DEPARTMENT OF THE CLINIC. THE PHYSICIAN QUESTIONED THE LOW APTT RESULT. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON AN ALTERNATE BCS XP SYSTEM USING THE BACKUP ASSAY AT 570 NM, RESULTING LOWER. THE REDRAWN LIPEMIC PATIENT SAMPLE WAS CENTRIFUGED AND RERUN ON THE ALTERNATE BCS XP SYSTEM USING THE BACKUP ASSAY AT 570 NM, RESULTING HIGHER THAN PREVIOUS RESULTS. THE CUSTOMER MANUALLY EVALUATED THE COAGULATION REACTION ON THIS KINETIC MEASURING CURVE AND REPORTED THE RESULT THAT THEY MANUALLY OBTAINED TO THE PHYSICIAN. THE REPORTED RESULT MATCHED THE PATIENT'S EXPECTED RESULT RANGE AND CLINICAL CONDITION. THE ORIGINAL PATIENT SAMPLE WAS CENTRIFUGED AND RERUN ON THE ALTERNATE SYSTEM- RESULTING IN A FLAGGED, BUT EXPECTED, APTT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727442 DADE ACTIN FS ACTIVATED PTT REAGENT DADE ACTIN FS ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FS ACTIVATED PTT REAGENT 538521

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR