BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 835632 · Received April 4, 2007

    Report

    Report Number
    2432235-2007-00010
    Event Type
    Other
    Date Received
    April 4, 2007
    Date of Event
    January 7, 2007
    Report Date
    January 26, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG LTD
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS DIAGNOSTICS FIELD SERVICE ENGINEER WAS SENT ON SITE AND FOUND THAT THE FLUID SENSOR FOR THE WASH 1 RESERVOIR DID NOT DETECT THAT THE RESERVOIR WAS EMPTY AND HAD THE SENSOR BEEN WORKING PROPERLY, IT WOULD HAVE ALERTED THE OPERATOR TO REPLACE THE WASH 1 BOTTLE. AS A RESULT OF THE EMPTY WASH RESERVOIR, THE SAMPLE WASH WAS INADEQUATE AND CAUSED THE DISCREPANT RESULT. THE FSE REPLACED THE WASH 1 RESERVOIR FLUID SENSOR AS WELL AS THE ASSOCIATED TUBING AND INTERCONNECT PCB AND THE SYSTEM IS FUNCTIONING AS INTENDED. FOR MEDICAL DEVICE REPORTING PURPOSES, THIS EVENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT IN 2007, THE PT WAS ADMITTED TO THE EMERGENCY ROOM FOR ATYPICAL CHEST AND STOMACH PAIN. SHE DID NOT SHOW CARDIO-BREATH DISTRESS OR HEART FAILURE. HER BODY TEMPERATURE WAS NORMAL AND OXYGEN SATURATION WAS 98%. THE ELECTROCARDIOGRAM SHOWED SINUSAL RHYTHM WITHOUT ST SEGMENT CHANGES. THE BIOLOGICAL ASSESSMENT SHOWED HIGH CREATINE PHOSPHOKINASE. SHE WAS TRANSFERRED TO THE CARDIOLOGICAL INTENSIVE CARE UNIT FOR AN ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT CHANGES ON THE ELECTROCARDIOGRAM. SHE RECEIVED AN ANTIPLATELET AND ANTICOAGULANT TREATMENT (LEVENOX, RISORDAN, PLAVIX, AND KARDEGIC). TWENTY HOURS LATER, A NEW BIOLOGICAL EXAM SHOWED A NEGATIVE TROPONIN RESULT OF 0.02 NG/ML. THE CLINICIAN QUESTIONED THIS RESULT AND REQUESTED THE LAB VERIFY THE TROPONIN RESULTS. THE INITIAL SAMPLES AT TIME 0 AND TIME 0+2 HOURS THAT WERE ORIGINALLY POSITIVE (7.81 NG/ML AND 17.7 NG/ML RESPECTIVELY) BOTH GAVE RETEST RESULTS OF <0.01 NG/ML. BASED ON THE REPEAT RESULTS, THE TREATMENT WAS CHANGED TO ONLY LOVENOX AT A LOWER DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY SYSTEM JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG LTD ADVIA CENTAUR *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other