BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2067526 · Received April 22, 2011

    Report

    Report Number
    2122870-2011-01119
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED TO DATE.PER THE CUSTOMER SUPPLIED QC CHARTS, ALL THREE LEVELS OF HYB-PSA QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. ON (B)(6) 2011, HYB-PSA QC RESULTED AS 0.00 NG/ML.PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS.CUSTOMER VERIFIED THAT THE HYB-PSA REAGENT PACK WAS IN THE PROPER LOCATION IN THE REAGENT CAROUSEL AND THEN REPEATED QC WITH FRESH MATERIAL AND RESULTS WERE 0.00 NG/ML.THE CUSTOMER PERFORMED A ROUTINE SYSTEM CHECK ON (B)(4) 2011, WHICH FAILED WITH A WASHED %CV.CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (TS) AND HAD THE CUSTOMER RE-POSITION THE FLUIDICS TRAY AND PRIME THE SUBSTRATE. THE CUSTOMER REPLACED THE HYB-PSA REAGENT PACK WITH A NEW PACK AND RE-RAN QC, WHICH RESULTED WITHIN NORMAL RANGE. ANOTHER ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS.SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE ISSUE WAS RESOLVED WITH NORMAL TROUBLESHOOTING WITH THE BCI HOTLINE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING LOWER THAN EXPECTED HYB-PSA RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR TWO (2) PATIENTS THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS WITHIN THE NORMAL REFERENCE RANGE BUT OUTSIDE OF ASSAY PRECISION CLAIMS FOR BOTH PATIENTS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1