BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2161019 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01661
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    August 9, 2007
    Report Date
    August 13, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER ON (B)(6) 2007 TO FOLLOW-UP ON THE EVENT. THE CUSTOMER STATED SHE WOULD CONTACT THE FSE IF FURTHER ASSISTANCE WAS REQUIRED. THE CUSTOMER COLLECTS SAMPLES IN PLASTIC GREINER LITHIUM HEPARIN TUBES WITH GEL. THE CUSTOMER CENTRIFUGED THE SAMPLES IN A FIXED ANGLE CENTRIFUGE. EXACT CENTRIFUGATION RPM (ROTATIONS PER MINUTE) AND TIME DATA WAS NOT SUPPLIED. THE SPECIMEN WAS SAMPLES FROM A 2 ML CUP. THE ORIGINAL SAMPLE WAS TESTED AT THE CUSTOMER SITE AND THE REPEAT SAMPLE WAS FROZEN PRIOR TO ANALYSIS. THE REPEATED SAMPLE WAS ALSO RE-SPUN. TROPONIN (ACCUTNI) AND CREATINE KINASE-MB (CK-MB) QUALITY CONTROL WERE WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT. SYSTEM CHECK DATA WAS NOT SUPPLIED BY THE CUSTOMER. BECKMAN COULTER'S CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY RECEIVED ONE PATIENT SAMPLE FOR INVESTIGATION. THE NEAT TROPONIN TEST WAS COMPARABLE TO THE CUSTOMER'S DOSE RESULTS. THERE WAS NO ENOUGH SAMPLE TO PERFORM DILUTION RECOVERY TESTING OR CK-MB TESTING. THE ADDITION OF IN-HOUSE "INTERFERENCE ELIMINATING PROTEINS" SIGNIFICANTLY DECREASED THE DOSE RECOVERY WHEN COMPARED TO THE NEAT PATIENT RESULTS. THE ROOT CAUSE FOR NON-CORRELATION IS ATTRIBUTED TO HETEROPHILE INTERFERENCE. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. IN ADDITION, ELEVATED TROPONIN-I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS TROPONIN (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED ELEVATED TROPONIN (ACCUTNI) AND CREATINE KINASE-MB (CK-MB) PATIENT RESULTS THAT DID NOT CORRELATE WITH THE HOSPITAL LABORATORY INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE TROPONIN RESULTS WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND NEGATIVE TROPONIN RESULTS WERE OBTAINED ON AN ALTERNATE METHODOLOGY. THE PATIENT'S TOTAL CREATINE KINASE (CK) WAS 211 IU/L AND ELECTROCARDIOGRAM (ECG) WAS NORMAL. THE ALTERNATE FACILITY OBTAINED TOTAL CK VALUES WITHIN NORMAL RANGE. THE CUSTOMER PERFORMED A MONO SPOT ON THE PATIENT'S PLASMA SAMPLE WHICH WAS NEGATIVE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS CK-MB| ACCESS ACCUTNI