BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2449254 · Received February 13, 2012

    Report

    Report Number
    2122870-2012-00362
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A REVIEW OF ORACLE SERVICE NOTES ON (B)(4) 2012 INDICATED THE CUSTOMER WENT THROUGH THE REAGENT INVENTORY LIST REPORT AND THE REAGENT PACKS ON THE CAROUSEL. A PROSTATE-SPECIFIC ANTIGEN (PSA) REAGENT PACK WAS LISTED ON THE INVENTORY LIST THAT DID NOT EXIST ON THE REAGENT CAROUSEL. THE PSA REAGENT WAS NOT USED. THE REPORT ALSO INDICATED 6 TO 7 THYROGLOBULIN PATIENT RESULTS HAD BEEN CLOSE TO ZERO BUT THESE RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THE CUSTOMER COMPLETED A PATIENT SAMPLE TEST AFTER COMPLETING CALIBRATION AND QUALITY CONTROL WITH A NEW REAGENT PACK; RESULTS WERE WITHIN SPECIFICATION. BECKMAN COULTER, INC. CUSTOMER TECHNICAL SERVICE (CTS) ADVISED THE CUSTOMER TO CORRECTLY LOAD AND SCAN REAGENT PACKS TO PREVENT PACK MIS-LOAD ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THYROGLOBULIN QUALITY CONTROL (QC) RESULTS WAS ZERO FOR ALL LEVELS, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER ATTEMPTED TO CALIBRATE, AND A 'BAD FIT' FAILURE WAS OBTAINED. BECKMAN COULTER, INC. CUSTOMER TECHNICAL SERVICE (CTS) ADVISED THE CUSTOMER TO USE PERSONAL PROTECTIVE EQUIPMENT (PPE) DURING TROUBLESHOOTING. THE CUSTOMER REMOVED THE REAGENT PACK AND DISCOVERED NO REAGENT PACK WAS PRESENT. THERE WAS 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS THYROGLOBULIN