BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2102303 · Received May 25, 2011

    Report

    Report Number
    1415939-2011-00161
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS EVALUATION BEGAN WITH A REVIEW OF THE JOURNAL ARTICLE THAT IS THE SUBJECT OF THIS REPORT. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR A PATIENT WHILE USING THE ARCHITECT INSTRUMENT AND AN UNKNOWN LOT OF THE ARCHITECT TROPONIN-I STAT ASSAY, LIST NUMBER (B)(4). THE CUSTOMER REPORTED THAT THE PATIENT'S TROPONIN RESULTS REMAINED ELEVATED, AND WERE NOT IN ALIGNMENT WITH OTHER DIAGNOSTIC TOOLS USED BY THE PATIENT'S PHYSICIANS (NORMAL ECG, PHYSICAL EXAMINATION, RADIOLOGICAL IMAGING AND ROUTINE LABORATORY INVESTIGATIONS). THE JOURNAL INVESTIGATORS FURTHER EVALUATED THE SAMPLE FOR THE PRESENCE OF INTERFERING SUBSTANCES. THE CUSTOMER REPORTED THAT THE TROPONIN CONCENTRATIONS WERE BELOW THE LEVEL OF DETECTION WHEN MEASURED USING ALL OTHER TROPONIN IMMUNOASSAYS (ABBOTT ARCHITECT EXCLUDED). THE SCIENTISTS (CUSTOMER) DID IDENTIFY THE PRESENCE OF A HIGH MOLECULAR WEIGHT IMMUNOREACTIVE PROTEIN, WHICH WAS IDENTIFIED AS A MACROCOMPLEX CONTAINING IGG AND FRAGMENTS OF CARDIAC TROPONIN-I. THE CUSTOMER CONCLUDED THAT THEY IDENTIFIED A FALSE POSITIVE CARDIAC TROPONIN-I RESULT CAUSED BY A TRUE MACROTROPONIN, CONTAINING IGG AND FRAGMENTS OF CARDIAC TROPONIN-I IMMUNOREACTIVE ONLY TO THE ABBOTT ARCHITECT STAT TROPONIN-I IMMUNOASSAY. THE JOURNAL INVESTIGATOR INDICATED THAT CLINICIANS SHOULD BE AWARE OF THIS INTERACTION WHEN A PATIENT PRESENTS WITH CONSISTENTLY ELEVATED TROPONIN LEVELS IN THE ABSENCE OF CORONARY CAUSES FOR THE ELEVATION. NO OTHER ISSUES WERE IDENTIFIED THAT REQUIRE INVESTIGATION. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT STAT TROPONIN-I ASSAY PACKAGE INSERT (REVISION 840653/R08) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THIS CURRENT EVALUATION, THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. LITERATURE CITATION: FALSE POSITIVE TROPONIN RESULT CAUSED BY A TRUE MACROTROPONIN. MICHIELSEN ETIENNE CHJ; BISSCHOPS PIETER GT; JANSSEN MARCEL JW. DEPARTMENT OF CLINICAL CHEMISTRY AND HEMATOLOGY, VIECURI MEDICAL CENTRE, VENLO, THE NETHERLANDS. CLINICAL CHEMISTRY AND LABORATORY MEDICINE - CCLM/FESCC (GERMANY) MAY 2011, 49(5) P923-5, ISSN: 1434-6621. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT FALSE POSITIVE RESULTS WERE GENERATED BY THE ARCHITECT STAT TROPONIN-I ASSAY. A (B)(6) FEMALE PATIENT PRESENTED WITH COMPLAINTS OF TIREDNESS, SHORTNESS OF BREATH AND RECENT ONSET OF CHEST PAINS. THIS PATIENT GENERATED AN ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 6.4 UG/L (ASSAY PACKAGE INSERT REFERENCE VALUE IS LESS THAN 0.03 UG/L). THIS PATIENT HAD A NORMAL ECG WITH NO ABNORMAL FINDINGS FROM A PHYSICAL EXAMINATION (INCLUDING NORMAL KIDNEY FUNCTION), RADIOLOGICAL IMAGING OR ROUTINE LABORATORY TESTING. HER TEMPERATURE WAS SLIGHTLY ELEVATED AT 38.1 DEGREES C. CONVENTIONAL THORAX IMAGING WAS NORMAL AND ECHOCARDIOGRAPHY SHOWED NORMAL LEFT AND RIGHT VENTRICULAR FUNCTION. NO PERICARDIAL EFFUSION WAS NOTED WITH NO REGIONAL MOVEMENT DISORDERS, RULING OUT MYOCARDITIS. THE PATIENT CONTINUED TO REMAIN DYSPNEIC WITH ARCHITECT STAT TROPONIN-I VALUES REMAINING ELEVATED AT APPROXIMATELY 6.0 UG/L. CT ANGIOGRAPHY WAS PERFORMED THAT RULED OUT PULMONARY EMBOLISM AND ANY OTHER INTRAPULMONARY ABERRATIONS. SAMPLES FROM THIS PATIENT TESTED NEGATIVE FOR TROPONIN-I WITH FOUR DIFFERENT NON-ABBOTT METHODOLOGIES. SERIAL DILUTIONS OF THE SAMPLE AND ADDITION OF MOUSE SERUM DID NOT CHANGE THE ARCHITECT STAT TROPONIN-I RESULTS. HOWEVER, POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND GEL FILTRATION CHROMATOGRAPHY (GFC) REVEALED THE PRESENCE OF A HIGH MOLECULAR WEIGHT IMMUNOREACTIVE PROTEIN. USING GFC AND PROTEIN-A IGG PRECIPITATION, THE INTERFERENCE COULD BE IDENTIFIED AS A MACRO-COMPLEX CONTAINING IGG AND (FRAGMENTS OF ) CTROPONIN-I. NOTE: DURING A TWO YEAR FOLLOW-UP AFTER INITIAL PRESENTATION, THE CARDIAC TROPONIN-I CONCENTRATION SLOWLY DECREASED TO A VALUE OF 3.3 UG/L AS MEASURED BY THE ARCHITECT STAT TROPONIN-I ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other ARCH I2000SR LN: 3M74-01 SN: (B)(4)| ARCH I2000SR LN: 3M74-01 SN: (B)(4)