BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2101325 · Received May 24, 2011

    Report

    Report Number
    2122870-2011-01560
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC BD SERUM TUBE WITH A GEL SEPARATOR, AND WAS CENTRIFUGED FOR > 5 MINUTES AT < 5000 RPM. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE CUSTOMER SENT THE SAMPLE TO BCI FOR ADDITIONAL TESTING. BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) WAS ABLE TO REPLICATE THE CUSTOMERS NEAT RESULT OF NO VALUE WITH AN IND FLAG. SUBSEQUENT TESTING WITH HETEROPHILE BLOCKING AGENTS SHOWED A SIGNIFICANT INCREASE IN DOSE, THUS INDICATING A PATIENT SOURCE INTERFERENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A PATIENT SOURCE INTERFERENT IS THE ROOT CAUSE OF THIS EVENT. IT WAS SAMPLE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NO VALUE IND FLAGGED PROGESTERONE RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING WITH A DILUTED SAMPLE PRODUCED A HIGHER RESULT. 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1