BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF AUTOLOADER

    MDR report key: 2260810 · Received September 22, 2011

    Report

    Report Number
    1061932-2011-01522
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED FOR SAMPLES RUN ON COULTER ACT 5DIFF AUTOLOADER. SAMPLES WERE COLLECTED IN BLUE TOPPED SODIUM CITRATE TUBES AT REFERENCE LAB. CONTROLS WERE RUN BEFORE BUT NOT AFTER INCIDENT. INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE PERFORMED RBC/PLT GAIN ADJUSTMENT AND RAN SEVERAL PATIENT SAMPLES, STARTUP, REPRODUCIBILITY AND QUALITY CONTROLS AND COULD NOT REPRODUCE REPORTED ISSUE. THE SYSTEM WAS VALIDATED. BASED ON INFORMATION PROVIDED THE ROOT CAUSE CAN NOT BE DETERMINED, BUT BOTH PATIENTS WERE OBSERVED TO HAVE PLATELET AGGREGATION. PER LABELING, INTERFERING SUBSTANCE, PLT: NOTE THAT, IN SOME PATIENTS, PLATELETS CAN AGGREGATE IN THE PRESENCE OF EDTA BECAUSE OF THE OCCURRENCE OF PLATELET-SPECIFIC ANTIBODIES. THIS MAY CAUSE AND ERRONEOUSLY LOW OR DECREASED PLATELET COUNT. PLT AGGLUTINATION: CLUMPED PLATELETS MAY CAUSE A DECREASED PLT COUNT AND/OR ELEVATED WBC COUNT; WBC, SL, AND SL1 FLAGS MAY BE GENERATED. REANALYZE THE SPECIMEN AS FOLLOWS: RECOLLECT THE SPECIMEN IN SODIUM CITRATE ANTICOAGULANT TO PREVENT PLATELET AGGLUTINATION. REANALYZE THE SPECIMEN FOR ONLY THE PLT COUNT. CORRECT THE FINAL PLT RESULT FOR THE EFFECT OF THE SODIUM CITRATE DILUTION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT 5DIFF AUTOLOADER (AL) GENERATED DISCORDANT RESULTS FOR RED CELL COUNT (RBC) AND PLATELETS (PLT) FOR TWO (2) PATIENTS. REVIEW OF THE DATA SHOWED THAT THE COULTER ACT 5DIFF AL GENERATED HIGH RBC, HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) AND LOW PLT FOR PATIENT 1 WITHOUT INSTRUMENT FLAGS. INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER PERFORMED AN EXTENDED CLEANING PROCEDURE, THEN REPEATED ANALYSIS OF PATIENT 2 SAMPLE. RESULTS SHOWED HIGHER PLT ON INITIAL AND RERUN 1 WITH INSTRUMENT GENERATED R FLAGS. RERUN 2 SHOWED LOWER WBC, RBC, HGB, AND HIGHER PLT RESULTS WITHOUT INSTRUMENT FLAGS. RERUNS 3, 4, AND 5 CORRELATED WITH INITIAL AND RERUN 1, EXCEPT PLT WAS LOWER WITH INSTRUMENT GENERATED FLAGS. BOTH PATIENTS WERE SENT TO A REFERENCE LAB AND REDRAWN WHERE PLATELET AGGREGATION WAS OBSERVED. REFERENCE RESULTS WERE CONSIDERED CORRECT; HOWEVER, REFERENCE PRINTOUTS ARE NO LONGER AVAILABLE AND LIS PRINTOUTS HAVE BEEN REQUESTED BUT NOT PROVIDED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 5DIFF AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. ACT 5DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR