BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF H10

    MDR report key: 5857568 · Received August 9, 2016

    Report

    Report Number
    1219913-2016-00132
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    June 19, 2016
    Report Date
    August 9, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    REF H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN AND CKMB RESULTS COMPARED TO LOWER CK RESULT WHEN RUN ON AN ALTERNATE TEST METHOD IN UNKNOWN. THE ERRONEOUS RESULT WAS RECOGNIZED AS BEING INCONSISTENT WITH THE PATIENT'S CLINICAL PICTURE, AND A SAMPLE SPECIFIC INTERFERENT MAY BE A CONTRIBUTING FACTOR. IMMUNOASSAYS ARE SUBJECT TO A NUMBER OF INTERFERENCES INCLUDING THOSE CAUSED BY ENDOGENOUS ANTIBODIES. INTERFERENCE CAN OCCUR BECAUSE OF HETEROPHILE ANTIBODIES, ANTI-ANIMAL ANTIBODIES AND AUTO ANTIBODIES. PATIENTS EXPOSED TO ANIMALS OR ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. THE INTERFERING ANTIBODIES CAN GIVE RISE TO A FALSELY HIGH OR LESS COMMONLY A FALSELY LOW RESULT. PLEASE NOTE THE INTERFERENT MAY NOT NECESSARILY BE DUE TO AN INTERFERING ANTIBODY BUT MAY BE DUE TO OTHER EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF THE INCIDENT. THE SAME PATIENT SAMPLES FROM THIS INCIDENT ARE NOT AVAILABLE FOR TESTING BY SIEMENS. NO CONCLUSION CAN BE DRAWN. SUSPECT MEDICAL DEVICE: BRAND NAME: ADVIA CENTAUR XP TROPONIN ULTRA. COMMON DEVICE NAME: TROPONIN IMMUNOASSAY. PRODUCT CODE: MMI. CATALOG #: 10317708. LOT #: 110. EXPIRATION DATE: 11/08/2016. PMA/510K: K053020. SUSPECT MEDICAL DEVICE: BRAND NAME: ADVIA CENTAUR XP CKMB. COMMON DEVICE NAME: CKMB IMMUNOASSAY. PRODUCT CODE: JHS. CATALOG #: 10309982. LOT #: 203. EXPIRATION DATE: 01/26/2017. PMA/510K: K962126. THE INSTRUCTION FOR USE (IFU) FOR ADVIA CENTAUR XP TROPONIN ULTRA UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS CHARACTERISTIC OF MI. IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF CTNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE CTNI RESULT. AN ELEVATED TROPONIN ALONE IS NOT SUFFICIENT TO MAKE THE DIAGNOSIS OF MI. OTHER MARKERS, SUCH AS CK-MB AND MYOGLOBIN, CAN BE USED IN CONJUNCTION WITH CTNI RESULTS IN AIDING THE DIAGNOSIS OF MI. A POSITIVE TROPONIN RESULT IS NOT ALWAYS INDICATIVE OF MI. THESE CONDITIONS INCLUDE, BUT ARE NOT LIMITED TO, MYOCARDITIS, CARDIAC SURGERY, ANGINA, UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, AND NON-CARDIAC RELATED CAUSES, SUCH AS, RENAL FAILURE AND PULMONARY EMBOLISM." THE INSTRUCTION FOR USE (IFU) FOR ADVIA CENTAUR XP CKMB UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "SERIAL SAMPLING AT THE APPROPRIATE TIME INTERVALS WILL RESULT IN THE TYPICAL RISE AND FALL PATTERN OF CK-MB LEVELS IN PATIENTS EXPERIENCING MYOCARDIAL INFARCTION. ELEVATED CK-MB LEVELS MAY BE RELATED TO NON-AMI EVENTS SUCH AS CONGESTIVE HEART FAILURE, STRENUOUS EXERCISE, OR TRAUMA. THESE EVENTS SHOULD BE CONSIDERED WHEN INTERPRETING CK-MB RESULTS."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) AND CKMB RESULT WAS OBSERVED BY THE CUSTOMER, AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE ELEVATED RESULTS WERE CONSIDERED DISCORDANT COMPARED TO A LOWER ALTERNATE TEST METHOD CK RESULT. THE PATIENT WAS PRESENTED TO EMERGENCY ROOM (ER) WITH HAND PAIN. THE PATIENT WAS REDRAWN AT A LATER DATE, AND THE RESULTS WERE SIMILAR. THE PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY FOR CREATINE KINASE (CK) ISOENZYME TESTING, AND THE RESULT WAS NEGATIVE FOR POTENTIAL MYOCARDIAL INJURY. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA AND CKMB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508816 REF H10 REF H10 MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A REF H10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR