BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2180979 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00683
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE AND PERFORMED TROUBLESHOOTING. THE FSE REPLACED THE RINSE CUP AND THE PROBE WIPE AND THEN VERIFIED THAT THE INSTRUMENT WAS PERFORMING CORRECTLY. THE ROOT CAUSE FOR THE EVENT IS UNK BUT MAY BE RELATED TO THE INSTRUMENT HARDWARE THAT WAS REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INCORPORATED (BCI) AND REPORTED THAT THEY WERE SEEING FLUID ON THE TOP OF THE SAMPLE TUBES ON THE COULTER AC-T DIFF 2 ANALYZER (AC-T DIFF 2) INSTRUMENT. THE AC-T INSTRUMENT HAD INCREASED ASPIRATION ERRORS AND EXCESSIVE FLUID DROPS WERE APPEARING ON THE SPECIMEN TUBE TOPS. PT RESULTS OBTAINED ON THE INSTRUMENT THAT DAY WERE REPORTED OUT OF THE LAB AND ALTHOUGH THEY WERE CONSIDERED TO BE CORRECT, THE CUSTOMER HAD THEM RECALLED AS A PRECAUTIONARY MEASURE. NONE OF THE SAMPLES ANALYZED THAT DAY WERE RERUN BUT INSTEAD THE CUSTOMER RESCHEDULED REDRAWS OF FRESH SAMPLES FROM ALL PTS. REDRAWN SAMPLES RESULTS WERE NOT PROVIDED. HOWEVER, SEVEN INITIAL RESULTS OBTAINED WERE PROVIDED. THIS INCIDENT WAS NOT CONSIDERED AN ADVERSE EVENT INVOLVING A BIO-HAZARDOUS EXPOSURE, SINCE THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AND THERE WAS NO EXPOSURE TO SKIN, OPEN LESIONS OR MUCOUS MEMBRANES AND THE OPERATOR AND OTHER PERSONNEL IN THE LAB DID NOT SEEK MEDICAL ATTENTION. ADDITIONALLY, THE CUSTOMER HAD ACCESS TO THE REAGENT MSDS (MATERIAL SAFETY DATA SHEETS) (BUT HAD NOT REVIEWED THEM) AND THERE WAS RISK MANAGEMENT PLAN IN PLACE AT THE SITE. THERE WERE NO ADVERSE EVENTS OR INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK