BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 6804933 · Received August 18, 2017

    Report

    Report Number
    9610806-2017-00092
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 18, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768003882
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) ANALYSED THE DATA PROVIDED BY THE CUSTOMER TO DETERMINE THE CAUSE OF THE DIFFERENT APTT RESULTS OBTAINED ACROSS DIFFERENT SYSTEMS FOR SAMPLE(S) FROM THIS PATIENT. SIEMENS DETERMINED THAT THE KINETIC REACTIONS FROM THE DATA PRINTOUT ARE CONSISTENT WITH PATIENT SAMPLES ON ARGATROBAN THERAPY. THE INTERNAL QUALITY CONTROLS ON THE BCS XP SYSTEM AND SYSMEX CA-7000 SYSTEM RECOVERED WITHIN EXPECTED RANGE AT THE TIME OF THE EVENT AND THERE IS NO INDICATION THAT OTHER PATIENTS WERE IMPACTED. THE AFFECTED PATIENT IS ON ARGATROBAN, A DIRECT THROMBIN INHIBITOR (DTI), WHICH INFLUENCES APTT RESULTS FOR ALL MANUFACTURERS' REAGENTS AND SYSTEMS. THE REAGENT AND THERAPEUTIC RANGE FOR ARGATROBAN USED ON THE STAGO SYSTEM WAS NOT PROVIDED, THEREFORE DIFFERENCES OF SENSITIVITY INHERENT TO BOTH REAGENT AND SYSTEMS CANNOT BE DETERMINED. APTT VALUES OF THERAPEUTIC SAMPLES BETWEEN SYSTEMS MAY BE NUMERICALLY DIFFERENT, HOWEVER STILL ACCURATE FOR THE INDEPENDENT SYSTEM THE SAMPLE WAS TESTED ON. REAGENT SENSITIVITY CAN VARY BETWEEN REAGENT PRODUCTS ACROSS DIFFERENT MANUFACTURERS. A DIRECT COMPARISON OF THE APTT RESULTS IS NOT POSSIBLE. SIEMENS DETERMINED THAT THE CUSTOMER REPORTED A NON-REPORTABLE, FLAGGED RESULT FROM THE SYSMEX CA-7000 SYSTEM. BASED ON THE SYSMEX "CA SERIES CHECKING METHODS AND EVALUATION GUIDE", ERE 1 (EARLY REACTION ERROR: SLOW REACTION) OCCURS WHEN THE SLOPE OF THE COAGULATION CURVE AROUND THE DETECTION POINT IS TOO LOW. THIS ERROR MAY BE REPORTABLE AFTER VISUAL REVIEW OF THE MEASUREMENT CURVE TO ENSURE THE APTT VALUE DETERMINED AT THE 50% IS CONSISTENT WITH THE KINETICS. ATO (ANALYSIS TIME OVER) DETECTS WHETHER THE REACTION END POINT IS CORRECT. IF THE SAMPLE REACTION END ANGLE IS GREATER THAN THE PERMITTED ANGLE AT THE MAXIMUM DETECTION TIME, THE RESULT WILL BE FLAGGED WITH AN ANALYSIS TIME OVER ERROR. IF THIS ERROR PERSISTS, AND ALTERNATE PROTOCOL SHOULD BE FOLLOWED. SIEMENS DETERMINED THAT THE REACTION CURVE FROM THE SYSMEX CA-7000 SYSTEM DEMONSTRATES INCREASING ANGLE IN THE PLATEAU AREA OF THE CURVE, HOWEVER CLOTTING WAS OBSERVED EARLIER ON THE REACTION CURVE. BASED ON THE SYSMEX BULLETIN AND GUIDES, OPERATORS CAN REPORT RESULTS WITH THE ERE1 FLAG BUT CANNOT REPORT RESULTS WITH THE ATO FLAG. THE CUSTOMER HAS IMPLEMENTED THEIR OWN POLICY TO ACCEPT ATO ERRORS WHEN CLEAR CLOTTING IS DEMONSTRATED. SIEMENS OFFERED TO PROVIDE FLAG INTERPRETATION AND RESULTS EVALUATION BULLETINS FOR THE SYSMEX CA-7000 SYSTEM AND THE BCS XP SYSTEM TO THE CUSTOMER AND THE CUSTOMER REJECTED THE OFFER. THE CUSTOMER STATED THAT THE LAB HAS THESE BULLETINS BUT WILL NOT CHANGE THEIR LAB POLICY-EVEN IF THEIR POLICY CONFLICTS WITH SIEMENS GUIDELINES. SIEMENS ALSO REVIEWED THE KINETIC CURVE ON THE BCS XP SYSTEM AND DETERMINED THAT THE BCS XP KINETIC CURVE DEMONSTRATES A PATTERN THAT IS CONSISTENT WITH PATIENTS ON ARGATROBAN THERAPY. THE KINETIC PROVIDED IS NOT FOCUSED ON THE AREA OF CLOTTING PREFERRED FOR INTERPRETATION OF THE CURVE. THE APTT RESULT WAS FLAGGED APPROPRIATELY AND THE CUSTOMER NEEDED TO SELECT "AUTO" TO APPROPRIATELY EVALUATE THE CURVE. THE CAUSE OF THE MODIFICATION OF THE PATIENT'S TREATMENT IS DUE TO USER ERROR AS THE CUSTOMER REPORTED NON-REPORTABLE, FLAGGED RESULTS. THE INSTRUMENTS AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2017-00091 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    FLAGGED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-7000 SYSTEM AND BCS XP SYSTEM. THE SAME PATIENT SAMPLE WAS SENT TO ANOTHER LAB AND RERUN ON AN ALTERNATE NON-SIEMENS (STAGO) SYSTEM, RESULTING HIGHER. THE CUSTOMER INDICATED THAT THE RESULT OBTAINED ON THE STAGO SYSTEM WAS THE CORRECT RESULT AND ONLY REPORTED THE FLAGGED APTT RESULT OF 78 SECONDS FROM THE SYSMEX CA-7000 SYSTEM AS IT WAS WITHIN THE RANGE OF THE APTT RESULT OBTAINED ON THE STAGO SYSTEM. APTT RESULTS RANGING IN 32.5 TO 70.3 SECONDS WERE ALSO OBTAINED ON SAMPLE(S) FROM THIS PATIENT ON THE STAGO SYSTEM. NONE OF THE RESULTS OBTAINED ON THE STAGO SYSTEM WERE REPORTED TO THE PHYSICIAN. THE MEDICAL STAFF ADJUSTED THE PATIENT'S ARGATROBAN TREATMENT BASED ON THE REPORTED APTT RESULT TO MAINTAIN THE PATIENT'S APTT RESULT(S) WITHIN THE THERAPEUTIC RANGE (40 - 80 SECONDS). THE MEDICAL STAFF MONITORS THE PATIENT'S APTT RESULT AND SENDS A SAMPLE FROM THE PATIENT TO THE LAB EVERY 3 HOURS, WHILE THE PATIENT IS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER REPORTING FLAGGED APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584303 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT 547484 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR