BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2741969 · Received September 12, 2012

    Report

    Report Number
    2122870-2012-01754
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. A FIELD SERVICE ENGINEER (FSE) PERFORMED A PASSING SYSTEM CHECK AND A PASSING HIGH SENSITIVITY SYSTEM CHECK WITHOUT PERFORMING ANY REPAIRS. THE INSTRUMENT PERFORMED AS INTENDED AND NO FAILURE WAS IDENTIFIED. THE CAUSE OF THE IMPRECISE ACCUTNI PATIENT RESULTS COULD NOT BE DETERMINED BASED ON THE SUPPLIED DOCUMENTATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION OF THE ASSAY, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT SAMPLE. THE PATIENT SAMPLE HAD PREVIOUSLY GENERATED AN ACCUTNI RESULT WHICH WAS HIGHER, BUT STILL WITHIN THE RISK STRATIFICATION OF THE ASSAY, FOR WHICH THE CUSTOMER HAD BEEN ADMITTED TO THE HOSPITAL. THIS RESULT WAS NOT IN QUESTION BY THE CUSTOMER. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON SUBSEQUENT REPEAT TESTING ON THE SAME INSTRUMENT, MULTIPLE HIGHER RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY WERE GENERATED WHICH CORROBORATED THE INITIAL ELEVATED ACCUTNI RESULT. COLLECTIVELY THE RESULTS EXCEEDED THE MARKETED PRECISION CLAIMS OF THE ASSAY. ADDITIONALLY, A SLIGHTLY ELEVATED CREATINE KINASE-MB ISOENZYME (CK-MB) RESULT WAS GENERATED FOR THIS PATIENT. THE IMPRECISE, LOW ACCUTNI RESULT WAS REPORTED OUT OF THE LABORATORY HOWEVER THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THE RESULT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT/ASSAY PERFORMANCE DATA INDICATED THAT QUALITY CONTROL PERFORMANCE WAS PASSING WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DATE OF THE EVENT. ROUTINE SYSTEM CHECKS PERFORMED PRIOR TO THE EVENT GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA SAMPLES TUBE. THE SAMPLE WAS CENTRIFUGED FOR THREE MINUTES AT FIVE THOUSAND ONE HUNDRED REVOLUTIONS PER MINUTE. THERE WAS NO FIBRIN PRESENT AND NO OTHER ISSUES WITH THE PATIENT SAMPLE. NO OTHER ASSAYS OR PATIENT RESULTS WERE IN QUESTION AS PART OF THIS EVENT. THE REAGENT AND CALIBRATOR LOTS LINKED TO THIS EVENT WERE 220592 AND 121451 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1