BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2102997 · Received May 25, 2011

    Report

    Report Number
    1061932-2011-00479
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 5CC VACUTAINER TUBE, STORED AT ROOM TEMPERATURE AND PROCESSED WITHIN 2 HOURS OF COLLECTION. QC WAS RUN BEFORE AND AFTER THE EVENT AND IS CURRENTLY PERFORMING WITHIN SPECIFICATIONS. PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE QC RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND RAN START-UP, LATRON AND QC; ALL PASSED INSTRUMENT VERIFICATION. WHOLE BLOOD SPECIMENS WERE PROCESSED TO CONFIRM CBC RECOVERY ISSUE WAS RESOLVED. THE INSTRUMENT WAS VALIDATED. BASED ON THE REVIEW OF THE RAW DATA PROVIDED, NO ABNORMALITY WITH THE SYSTEM CAN BE ESTABLISHED. THE ROOT CAUSE BASED ON DATA PROVIDED IS MOST LIKELY SAMPLE RELATED. THE PATIENT'S RESULTS ARE INDICATIVE OF INADEQUATE MIXING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT COULTER LH 750 ANALYZER GENERATED INCORRECT LOW WHITE BLOOD COUNT (WBC), PLATELET (PLT) AND HIGH RED BLOOD COUNT (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS FOR ONE PATIENT SAMPLE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THE DELTA CHECK FOR THIS PATIENT ALERTED THE OPERATOR TO RERUN THE SPECIMEN. THE ORIGINAL SPECIMEN WAS RETESTED ON A DIFFERENT INSTRUMENT WHICH GAVE DIFFERENT RESULTS. THE SAMPLE WAS THEN RERUN ON THE LH750 INSTRUMENT WITH RESULTS MATCHING THE DIFFERENT INSTRUMENT AND CONSIDERED CORRECT. THERE WAS NO EFFECT TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1