BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3002642 · Received March 13, 2013

    Report

    Report Number
    1061932-2013-00400
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN BECTON DICKINSON HEMOGARD VACUTAINER, 3-4 ML TUBE AND WAS RUN SHORTLY AFTER COLLECTION. THE UNIT HAS BEEN PERFORMING WITHIN QC SPECIFICATIONS. THERE WAS NO SERVICE DISPATCHED FOR THIS EVENT. A DEFINITIVE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED BUT IS LIKELY SAMPLE SPECIFIC. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2013-00326, 1061932-2013-00327, 1061932-2013-00400.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT AN UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS DIFFERENTIAL (DIFF) RESULTS WHEN COMPARED TO MANUAL SMEAR RESULTS (WHICH WERE CONSIDERED CORRECT) FOR A SINGLE PATIENT WITH A HISTORY OF LEUKOPENIA (LOW WHITE BLOOD CELL COUNT). THIS REPORT DOCUMENTS THE RERUN ON A COULTER LH 750 HEMATOLOGY ANALYZER AT THE SAME ACCOUNT WHERE THE SAME ERRONEOUS DIFF RESULTS WERE OBTAINED FOR THE SAME PATIENT. BEC REVIEW OF THE DATA SHOWED ERRONEOUS HIGH NEUTROPHIL (NE%) AND LOW LYMPHOCYTE (LY%) RESULTS OBTAINED ON THE DXH800, WITH NO INSTRUMENT GENERATED FLAGS ON (B)(6) 2013 (DOCUMENTED IN MDR#1061932-2013-00327) AND SIMILAR HIGH NE% AND LOW LY% RESULTS ON (B)(6) 2013 (DOCUMENTED IN MDR 1061932-2013-00326); HOWEVER, FLAGGING ON (B)(6) 2013 COULD NOT BE ASSESSED, AS NO INSTRUMENT PRINTOUT WAS PROVIDED, JUST THE LIS (LABORATORY INFORMATION SYSTEM) REPORT. HIGH NE% AND LOW LY% RESULTS WERE ALSO OBTAINED ON THE LH750 INSTRUMENT AT THE SAME ACCOUNT (DOCUMENTED IN THIS REPORT) FOR THE RERUN RESULTS ON (B)(6) 2013, WITH NO INSTRUMENT GENERATED FLAGS, WHEN COMPARED TO THE MANUAL (WHICH WERE CONSIDERED CORRECT). THE SAMPLE FROM (B)(6) 2013 WAS SENT TO A SISTER HOSPITAL 36 HOURS LATER AND RUN ON TWO LH750 INSTRUMENTS. INSTRUMENT PRINTOUTS WERE NOT PROVIDED FOR THE TWO LH750 INSTRUMENTS AT THE SISTER ACCOUNT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT. A BONE MARROW PROCEDURE WAS ORDERED AS A CONSEQUENCE OF THE PATIENT'S CONTINUED LEUKOPENIA. PER CONVERSATION WITH CUSTOMER ON (B)(6) 2013, THE PROCEDURE WAS UNSUCCESSFUL, AS THEY WERE UNABLE TO OBTAIN A SAMPLE. THE BONE MARROW PROCEDURE WAS NOT RELATED TO THE RESULTS OBTAINED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104641 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1