BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2233731 · Received September 3, 2011

    Report

    Report Number
    2122870-2011-03165
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A BD SERUM SEPARATOR TUBE WITH AN ALLOTTED CLOT TIME OF 30 MINUTES. THE SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR AN UNSPECIFIED TIME. THE SAMPLE HAD BEEN STORED FOR 5 DAYS AT REFRIGERATED TEMPERATURE BEFORE TESTING. PER THE CUSTOMER COMPLAINT RECORDS, THE CUSTOMER RAN A SYSTEM CHECK ON (B)(4) 2011. ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. QC IS RUN DAILY AND ON EACH REAGENT PACK. QC WAS WITHIN ESTABLISHED RANGE PRIOR TO THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REBUILT THE PRECISION PUMP AND VALVE. THE FSE ALSO CONFIRMED ALIGNMENTS OF MAIN PIPETTOR. ALTHOUGH THE FSE ADDRESSED SEVERAL HARDWARE ISSUES, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING DISCREPANT RESULTS FOR DIL-HCG (DIL - HUMAN CHORIONIC GONADOTROPIN) ONE PATIENT'S SAMPLE OUTSIDE OF ASSAY PRECISION CLAIMS, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. ALL RESULTS OBTAINED WERE POSITIVE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER 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 JJE BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1