BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2228044 · Received August 30, 2011

    Report

    Report Number
    2122870-2011-03110
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) RAN A CARRYOVER TEST, PRECISION ASSESSMENT AND INSTRUMENT SYSTEM CHECK. ALL TESTING GENERATED RESULTS THAT MET PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MULTIPLE, HIGHER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB-PSA) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR TWENTY PATIENT SAMPLES ON (B)(6) 2011. THE INITIAL TWENTY HYB-PSA RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY A NURSE BECAUSE THEY APPEARED HIGHER THAN WAS HISTORICALLY OBSERVED FOR THE PATIENTS. UPON REPEAT ON THE SAME INSTRUMENT, THE HYB-PSA RESULTS WERE AGAIN HIGHER THAN EXPECTED AND CORRELATED TO THE INITIAL RESULTS. THE FOLLOWING DAY, THE INSTRUMENT HYB-PSA QUALITY CONTROL (QC) RESULTS DID NOT MEET CUSTOMER ESTABLISHED SPECIFICATIONS. THE CUSTOMER ANALYZED THE INSTRUMENT'S INITIAL CALIBRATION AND FOUND THE S0 RELATIVE LIGHT UNITS (RLU) MEAN TO BE ELEVATED. THE INSTRUMENT WAS RECALIBRATED, HOWEVER TESTING OF A FOUR -PATIENT SAMPLE SIZE GENERATED LOW OR INDETERMINATE VALUES. A NEW HYB-PSA REAGENT LOT WAS LOADED AND THE INSTRUMENT WAS RECALIBRATED AGAIN. QC RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATION. SUBSEQUENTLY, INITIAL HYB-PSA RESULTS WERE REPEATED ON THE SAME INSTRUMENT AFTER THE NEW REAGENT'S CALIBRATION AND THE RESULTS WERE LOWER BUT STILL WITHIN THE NORMAL REFERENCE RANGE. COLLECTIVELY THE INITIAL AND MULTIPLE REPEAT HYB-PSA RESULTS WERE OUTSIDE THE ASSAY'S PRECISION CLAIMS. ALTHOUGH THE IMPRECISE RESULTS WERE RELEASED FROM THE LABORATORY THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. INSTRUMENT SYSTEM CHECK REPORTS GENERATED PRIOR TO THE EVENT INDICATED THAT ALL PORTIONS WERE WITHIN PUBLISHED SPECIFICATIONS. THE SAMPLES WERE SERUM SAMPLES AND WERE COLLECTED ONSITE OR AT A SISTER CLINIC. THE SAMPLES WERE SPUN PRIOR TO TESTING AND TESTING WAS PERFORMED FROM THE PRIMARY COLLECTION TUBES. THE CUSTOMER DID NOT RESPIN THE SAMPLES PRIOR TO REPEAT TESTING. THE SAMPLES WERE REFRIGERATED BETWEEN TESTING. IT IS UNKNOWN WHETHER THE SAMPLES WERE FULL DRAWS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYBRITECH PSA REAGENT