BEUDAMED
    FDA Adverse Event Death Summary report: N

    DADE ACTIN FS ACTIVATED PTT REAGENT

    MDR report key: 19816285 · Received July 24, 2024

    Report

    Report Number
    9610806-2024-00019
    Event Type
    Death
    Date Received
    July 24, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768030826
    PMA / PMN Number
    K811589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). ALTHOUGH THE SYSMEX CS2500 SYSTEM DISPLAYED A FLAG "NO COAGULATION" AND DID NOT GIVE A NUMERIC APTT RESULT, THE CUSTOMER REPORTED MANUALLY EXTRAPOLATED NUMERIC APTT RESULTS WITHOUT THE ASSOCIATED SYSTEM FLAGS. REGARDING THE "NO COAGULATION" FLAG: 0032.0000.0000 NO COAGULATION, THE FOLLOWING INFORMATION IS GIVEN WITHIN THE INSTRUCTION MANUAL OF THE CS-2500 SYSTEM: "POSSIBLE CAUSE: THE COAGULATION REACTION WAS NOT DETECTABLE, DUE TO LOW FIBRINOGEN CONCENTRATION, AN ANTICOAGULANT SAMPLE OR A REAGENT PROBLEM. CORRECTIVE ACTIONS/COUNTERMEASURES: REANALYZE AND MAKE A COMPREHENSIVE JUDGMENT, TAKING SAMPLE AND REAGENT, ETC. INTO CONSIDERATION. ALSO, SET A LONGER DETECTION TIME AND REPEAT THE ANALYSIS." THE CS-2500 EVALUATION AND CHECK ALGORITHM DOCUMENT CONTAINS THE FOLLOWING: "ACTION STEPS FOR "NO COAGULATION" 1. CHECK THE SAMPLE FOR POSSIBLE ANTICOAGULANT CONTAMINATION, HEMOLYSIS, LIPEMIA, ETC. 2. VERIFY DELIVERY OF SAMPLE AND REAGENT. 3. REANALYZE THE SAMPLE. FOR FIBRINOGEN, IF AUTO RE-DILUTION IS NOT SET, CHANGE THE DILUTION RATIO AND REANALYZE. 4. IF REANALYSIS GIVES "NO COAGULATION" MESSAGE AGAIN, THE SAMPLE IS BELOW THE DETECTION LIMITS OF THE DETECTOR. USE AN ALTERNATE METHOD TO CONFIRM THE DATA. *DO NOT REPORT RESULTS WITHOUT NUMERICAL VALUES*" THE ISSUE WAS CAUSED BY A USE ERROR AS THE SYSTEM GAVE NO NUMERIC RESULTS AND FLAGGED THE MEASUREMENT ACCORDINGLY, BUT THE CUSTOMER MANUALLY ESTIMATED AND REPORTED RESULTS WITHOUT THE ASSOCIATED SYSTEM FLAGS. THE PHYSICIAN COULD NOT DEFINITIVELY CONCLUDE THE CAUSE OF THE PATIENT¿S DEATH TAKING INTO CONSIDERATION THE PATIENT¿S MEDICAL CONDITION (LAE (PULMONARY ARTERY EMBOLISM) ) AND THE BLEEDING COMPLICATION DUE TO THE HEPARIN OVERDOSE THAT OCCURRED AS A RESULT OF THE APTT MISIDENTIFICATION (OR THE SUBSEQUENT HIGH DOSAGE OF THE HEPARIN PERFUSOR). THE PHYSICIAN ALSO POINTED OUT THAT NO VALUE WAS INCORRECTLY DETERMINED BY THE DEVICE. AN EMPLOYEE OF THE LABORATORY MANUALLY EXTRAPOLATED NUMERIC APTT RESULTS AND THEREFORE ISSUED A FALSE APTT FINDING. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE SIEMENS DADE ACTIN FS ACTIVATED PTT REAGENT IS MARKETED IN THE UNITED STATES UNDER MATERIAL NUMBER 10445712. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT A WOMAN CAME TO THE EMERGENCY ROOM WITH ACUTE PULMONARY ARTERY EMBOLISM (LAE) WITH HEMODYNAMIC INSTABILITY, SHORT-TERM RESUSCITATION, AND ACIDOSIS. THE PATIENT WAS TESTED FOR D-DIMER AND THE PATIENT WAS ADMINISTERED HEPARIN BASED ON THEIR HIGH D-DIMER RESULT. THE PATIENT WAS ADMINISTERED A HEPARIN BOLUS OF 4000 IU AND A HEPARIN PERFUSOR WAS RUN AT 1000 IU/HR. THE PATIENT WAS LATER TESTED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) ON THE SYSMEX CS-2500 SYSTEM (LEGAL MANUFACTURE: SYSMEX) USING SIEMENS DADE ACTIN FS ACTIVATED PTT REAGENT. THE SYSTEM GAVE A NON-NUMERIC RESULT WITH A "NO COAGULATION" FLAG, HOWEVER, THE CUSTOMER INCORRECTLY REPORTED A NUMERIC APTT RESULT DERIVED BY THE CUSTOMER USING THE GRAPH FROM THE SYSTEM AND EXTRAPOLATING A VALUE, AND SUBSEQUENTLY THE HEPARIN PERFUSOR WAS INCREASED TO 1200 IU/HR. 4-5 HOURS LATER, THE PATIENT DEVELOPED SWELLING ON HER NECK AND SHORTNESS OF BREATH, SO SHE HAD TO BE INTUBATED. CT MORPHOLOGY SHOWED THAT THE PATIENT HAD A HEMATOMA. APTT WAS THEN TESTED AND THE SYSTEM GAVE A NON-NUMERIC RESULT WITH A "NO COAGULATION" FLAG. THE CUSTOMER MANUALLY DERIVED A VALUE TO BE HIGHER THAN THE INITIAL RESULT BY USING THE GRAPH FROM THE SYSTEM AND EXTRAPOLATING. HEPARIN PERFUSION WAS THEN STOPPED. THE PATIENT WAS THEN TESTED AGAIN FOR APTT, AND THE SYSTEM GAVE A NON-NUMERIC RESULT WITH A "NO COAGULATION" FLAG. THE CUSTOMER AGAIN INCORRECTLY REPORTED A NUMERIC APTT RESULT AND HEPARIN PERFUSION WAS RESTARTED AT 400 IU/HR. THE NEXT TEST FOR APTT AGAIN GAVE A NON-NUMERIC RESULT WITH A "NO COAGULATION" FLAG HOWEVER, THE CUSTOMER MANUALLY DERIVED A VALUE TO BE HIGHER THAN THE INITIAL RESULT BY USING THE GRAPH FROM THE SYSTEM AND EXTRAPOLATING AND HEPARIN PERFUSION WAS AGAIN STOPPED. IN THE NEXT FEW DAYS, THE PATIENT'S HEMATOMA SPREAD. THE PATIENT UNDERWENT A TRACHEOSTOMY, BUT THE DISEASE STILL PROGRESSED. SIEMENS WAS NOTIFIED ON 16-JUL-2024 THAT THE PATIENT EXPIRED ON (B)(6) 2024. STATEMENTS AND ACTIONS ATTRIBUTED TO THE PHYSICIAN(S) AND CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371552 DADE ACTIN FS ACTIVATED PTT REAGENT DADE ACTIN FS ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FS ACTIVATED PTT REAGENT 562438 00842768030826

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death