BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230310 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03353
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATE PROBES, DISPENSE PROBES AND INSTRUMENT CASE FAN THAT WAS NOT FUNCTIONING. THE FSE VERIFIED INSTRUMENT OPERATION BY PERFORMING 8 TEST REPLICATES OF ACCUTNI LEVEL 2 QC WITH ACCEPTABLE RESULTS. ALTHOUGH THE FSE COMPLETED SEVERAL REPAIRS AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES. THE INITIAL ACCUTNI RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY A PHYSICIAN AS THEY DID NOT MEET THE PATIENTS' CLINICAL PICTURES. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. ONE OF THE PATIENT SAMPLES WAS RETESTED ON THE SAME INSTRUMENT AND GENERATED LOWER RESULTS. IT IS UNKNOWN AS TO WHETHER THE SECOND PATIENT SAMPLE WAS RETESTED. IN AN ATTEMPT DETERMINE WHETHER THE ISSUE WAS INSTRUMENT OR ASSAY RELATED, THE CUSTOMER REPEATED FIVE KNOWN AND VALID NEGATIVE CREATINE KINASE-MB ISOENZYME (CK-MB) PATIENT SAMPLES ON THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT, THE SAMPLES RECOVERED WITH POSITIVE CKMB RESULTS. THESE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE ACCUTNI RESULTS WERE COLLECTED IN LITHIUM HEPARIN PLASMA SAMPLE TUBES AND WERE CENTRIFUGED PRIOR TO TESTING. TESTING OCCURRED FROM THE PRIMARY TUBE THAT WAS APPROXIMATELY THREE HOURS AND STORED AT ROOM TEMPERATURE. INSTRUMENT ACCUTNI QUALITY CONTROL (QC) RESULTS GENERATED PRIOR TO THE EVENT WERE BELOW ESTABLISHED CUSTOMER SPECIFICATION LIMITS, HOWEVER UPON RECALIBRATION, QC RESULTS RECOVERED WITHIN SPECIFICATION. INSTRUMENT SYSTEM CHECK RESULTS RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT, BUT FAILED TO MEET SPECIFICATIONS AFTER THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT