BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6631952 · Received June 9, 2017

    Report

    Report Number
    9610806-2017-00062
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 10, 2017
    Report Date
    July 11, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTIC INC. (SIEMENS) IS CURRENTLY INVESTIGATING THE CAUSE OF THE DIFFERENCES IN PROTHROMBIN TIME (PT) RESULTS BETWEEN DIFFERENT HOSPITALS.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTIC INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00062 ON JUNE 9, 2017. JUNE 15, 2017 ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTIC INC. (SIEMENS) ANALYZED THE AFFECTED PROTHROMBIN TIME (PT) RESULTS OBTAINED FROM THE SYSMEX CA-1500 SYSTEM. THE INSTRUMENT PERFORMED ACCORDING TO SPECIFICATIONS AFTER THE OPERATOR PERFORMED A MAINTENANCE CYCLE AND CREATED NEW CALIBRATION CURVES. THE OPERATOR RAN AND PASSED INTERNAL QUALITY CONTROLS. NO TECHNICAL INTERVENTION WAS REQUIRED AND NO OTHER PATIENT PT INR RESULTS AND CONTROLS WERE AFFECTED. THE DIFFERENCE IN RESULTS BETWEEN THE TWO DIFFERENT LAB/ASSAYS IS POTENTIALLY DUE TO A SAMPLE SPECIFIC INTERFERENCE. EXAMPLES OF THIS INTERFERENCE ARE LUPUS ANTICOAGULANTS, FACTOR ABNORMALITIES, OR OTHER MEDICATION INTERFERENCES. THE OPERATOR DID NOT REPORT THE PROTHROMBIN TIME (PT) RESULTS OBTAINED FROM THE AFFECTED SYSMEX CA-1500 SYSTEM. PT RESULTS OF 21.0% AND 2.87 INR WERE OBTAINED ON THIS PATIENT SAMPLE ON THE BCS XP SYSTEM WITH INNOVIN REAGENT AT ANOTHER LABORATORY. THE OPERATOR DOES NOT HAVE THE PATIENT'S MEDICAL HISTORY AND REPORTED THE RESULTS FROM THE OTHER LAB. THE OPERATOR STATED THAT THE PT RESULTS FROM THE OTHER LAB SEEM TO BE MORE APPROPRIATE. THE OPERATOR USED THE ACTIN FS REAGENT TO OBTAIN THE ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT. THE LOT NUMBER FOR THIS ACTIN FS REAGENT IS 557217A. THE INSTRUMENT AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2017-00061 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    PROTHROMBIN TIME (PT) RESULTS OF 84.7 SECONDS, 5.0% AND 8.36 INTERNATIONAL NORMALIZED RATIO (INR) WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-1500 SYSTEM USING THE DADE INNOVIN REAGENT. IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR ALSO OBTAINED AN ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF 60 SECONDS ON THIS PATIENT SAMPLE. THE REAGENT USED TO TEST FOR APTT IS UNKNOWN. IT IS ALSO UNKNOWN WHETHER THIS RESULT WAS REPORTED TO THE PHYSICIAN. AFTER OBTAINING THESE RESULTS, THE PATIENT BLOOD WAS RE-DRAWN AND RUN AT ANOTHER HOSPITAL. PT RESULTS OF 21.0% AND 2.87 INR AND A APTT RESULT OF 68 SECONDS WERE OBTAINED ON THIS PATIENT SAMPLE. THE INSTRUMENTS AND REAGENTS USED TO TEST THE RE-DRAWN PATIENT SAMPLE AT THE OTHER HOSPITAL IS UNKNOWN. IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR QUESTIONED THE DIFFERENCES BETWEEN THE RESULTS OBTAINED FROM THE OPERATOR'S LAB AND THE OTHER HOSPITAL. THE CORRECT RESULT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCES IN PT RESULTS OBTAINED BETWEEN DIFFERENT HOSPITALS ON THE PATIENT SAMPLES.

    Description of Event or Problem · 1

    PROTHROMBIN TIME (PT) RESULTS OF 84.7 SECONDS, 5.0 % AND 8.36 INTERNATIONAL NORMALIZED RATIO (INR) WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-1500 SYSTEM USING THE DADE INNOVIN REAGENT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE OPERATOR ALSO OBTAINED AN ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF 60 SECONDS ON THIS PATIENT SAMPLE USING THE ACTIN FS REAGENT. AFTER OBTAINING THESE RESULTS, THE PATIENT BLOOD WAS RE-DRAWN AND RUN AT ANOTHER LAB. PT RESULTS OF 21.0% AND 2.87 INR AND AN APTT RESULT OF 68 SECONDS WERE OBTAINED ON THIS PATIENT SAMPLE ON THE BCS XP SYSTEM USING THE DADE INNOVIN REAGENT. THE OPERATOR QUESTIONED THE DIFFERENCES BETWEEN THE RESULTS OBTAINED FROM THE OPERATOR'S LAB AND THE OTHER LAB. THE OPERATOR DOES NOT HAVE THE PATIENT'S MEDICAL HISTORY AND REPORTED THE RESULTS FROM THE OTHER LAB. THE OPERATOR INDICATED THAT THE PT RESULTS FROM THE OTHER LAB SEEM TO BE MORE APPROPRIATE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCES IN PT RESULTS OBTAINED BETWEEN DIFFERENT LABS ON THE PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413334 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN 539381A

    Patients

    Seq Age Sex Outcome Treatment
    1