BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2110138 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00527
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 5ML GREINER VACUETTE EDTA TUBES. CONTROLS WERE RUN BEFORE THE EVENT AND DID NOT RECOVER WITHIN ASSAY LIMITS. RAW DATA WAS REQUESTED BUT NOT PROVIDED BCI FIELD SERVICE ENGINEER (FSE) REPAIRED THE CONNECTION ON THE LS PREAMP. THE FSE VERIFIED INSTRUMENT OPERATION. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROL RECOVERIES AND REPRODUCIBILITY. THE ROOT CAUSE IS THE CONNECTION TO THE LS PREAMP THAT WAS REPAIRED DURING SUBSEQUENT INSTRUMENT SERVICING FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUSLY HIGH NEUTROPHILS (NE%) AND MONOCYTES (MO%), AND ERRONEOUSLY LOW LYMPHOCYTES (LY%) RESULTS GENERATED BY COULTER LH750 HEMATOLOGY ANALYZER ON THREE PATIENT SAMPLES. THE INSTRUMENT DID NOT GENERATE FLAGS, AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. AFTER REPORTING THE RESULTS, THE OPERATOR DISCOVERED THAT THE CONTROLS WERE RECOVERING OUTSIDE ASSAY LIMITS AND THAT DIFFERENTIAL RESULT FROM A SURVEY THAT WAS RUN ON A BACKUP INSTRUMENT DID NOT MATCH THE LH750 INSTRUMENT RESULTS. PATIENTS #1 AND #2 WERE RERUN ON THE BACKUP INSTRUMENT AND RECOVERED NORMAL DIFFERENTIAL RESULTS. THE CUSTOMER USED THESE IN THE CORRECTED REPORT. PATIENT #3 WAS RERUN ON THE SAME INSTRUMENT AND RECOVERED SIMILAR ERRONEOUS DIFFERENTIAL RESULTS. THE SAME SPECIMEN WAS THEN RUN ON THE BACKUP INSTRUMENT AND RECOVERED NORMAL DIFFERENTIAL RESULTS. THE CUSTOMER CONSIDERED THE RESULTS FROM THE BACKUP INSTRUMENT TO BE CORRECT AND SENT OUT A CORRECTED REPORT. THE CUSTOMER STATED THAT THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1