BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2122562 · Received June 14, 2011

    Report

    Report Number
    2122870-2011-01827
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 25, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE ASPIRATE PROBE TUBING WAS TANGLED, LIKELY FROM THE CUSTOMER DOING WEEKLY MAINTENANCE. THE ASPIRATE PROBE TUBING WAS REPLACED AND ALIGNED. A SUBSEQUENT SYSTEM CHECK FAILED DUE TO EXCESSIVE WASHED %CV (%COEFFICIENT OF VARIATION). IT WAS ALSO IDENTIFIED THAT THE UNIVERSAL MIXER TENSION WAS LOOSE AND CAUSED THE RV TO VIBRATE, AND NOT SPIN WELL, CAUSING SPLASHING. THE APPROPRIATE EQUIPMENT ADJUSTMENTS WERE MADE, AND A SUBSEQUENT SYSTEM CHECK WAS EXECUTED WHICH PASSED PUBLISHED SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED AND RETURNED INTO SERVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BCI) REPRESENTATIVE, DURING THE REVIEW OF A CUSTOMER'S SERVICE HISTORY FOR AN ACCESS 2 IMMUNOASSAY SYSTEM, IDENTIFIED THAT THE CUSTOMER HAD EXPERIENCED FAILING QUALITY CONTROL (QC) LEVEL 1 RESULTS ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR HUMAN CHORIONIC GONADOTROPIN (BHCG) ASSAY. DATA PROVIDED BY THE CUSTOMER INDICATED THAT THE ELEVATED S0 RELATIVE LIGHT UNITS (RLUS) HAD IMPACTED THE BHCG LOW LEVEL QC AND CAUSED IT TO FAIL. BCI INC. ADVISED THE CUSTOMER TO RECALIBRATE THE ASSAY BASED UPON THIS INFORMATION. SUBSEQUENTLY, LEVEL 2 QC RESULTS EXCEEDED CUSTOMER ESTABLISHED QC UPPER SPECIFICATIONS. THE CUSTOMER INDICATED THAT NO ERRONEOUS BHCG RESULTS WERE RELEASED DURING THE TIMEFRAME OF THIS EVENT, HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT IMPACT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT