BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750

    MDR report key: 1170257 · Received September 11, 2008

    Report

    Report Number
    1061932-2008-00049
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMED BEFORE AND AFTER THE EVENT AND WAS WITHIN SPECIFICATIONS. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO ACCURACY AND PRECISION. THE SPECIMEN WAS COLLECTED IN A 5ML VACUTAINER TUBE STORED AT ROOM TEMPERATURE. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. PER LABELING, PLATELET CLUMPS ARE KNOWN INTERFERING SUBSTANCE FOR THIS METHOD. BASED ON THE RAW DATA ANALYSIS, IN THIS SPECIFIC CASE, THE DATA PATTERN FROM SMALL PLT CLUMPS SAMPLES IS VERY SIMILAR TO THOSE FROM GIANT PLT SAMPLES. SOFTWARE FLAGGING ALGORITHM IS NOT SENSITIVE ENOUGH TO TELL THE DIFFERENCE. IN ADDITION, THE ORIGINAL RUN FOR THE SAMPLE HAD RELATIVELY LESS SEVERE PLT CLUMPS AND ITS CHARACTERISTICS DID NOT TRIGGER THE INSTRUMENT FLAGGING CRITERIA. BCI DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BCI SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. ALTHOUGH THE INTERFERENCE WAS NOT SIGNIFICANT ENOUGH TO TRIGGER THE INSTRUMENT FLAGGING, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING AN ERRONEOUSLY LOW PLATELET (PLT) RESULT, WITHOUT INSTRUMENT GENERATED FLAGS, THAT WAS GENERATED BY THE COULTER LH 750 ANALYZER FOR A SINGLE PATIENT. THE INITIAL PLT RESULT OF 83X10 TO THE THIRD POWER CELLS/UL WAS REPORTED OUT OF THE LAB. A PLT ESTIMATE WAS PERFORMED AND A HIGHER PLT COUNT WAS OBTAINED (142X10 TO THE THIRD POWER CELLS/UL) AND PLT CLUMPS WERE SEEN ON THE SMEAR. A CORRECTED REPORT WAS SENT OUT. THE SAMPLE WAS RERUN ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND PLT RESULT WAS 53X10 TO THE THIRD POWER CELLS/UL WITH A "GIANT PLTS" INSTRUMENT GENERATED FLAG. THE CUSTOMER THEN RERUN THE SAMPLE ON THE LH 750 INSTRUMENT AND A RESULT OF 56X10 TO THE THIRD POWER CELLS/UL WAS OBTAINED. THIS RESULT ALSO HAD INSTRUMENT GENERATED FLAGS. NO INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA