BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREPPLUS 2

    MDR report key: 2142028 · Received June 28, 2011

    Report

    Report Number
    1061932-2011-00756
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE. THE FIELD SERVICE ENGINEER REPLACED THE SYRINGE, PROBE AND ISO BLOCK. PERFORMANCE VERIFICATION WAS PERFORMED TO CONFIRM APPROPRIATE REAGENT DISPENSING, AND FAULT TESTING FOR GENERATION OF APPLICABLE ERROR MESSAGES. THE INSTRUMENT MET SPECIFICATIONS. THE ROOT CAUSE OF THE EVENT WAS THE REAGENT BOTTLE RUNNING EMPTY. BECKMAN COULTER LABELING STATES THE CUSTOMER SHOULD "CHECK THAT EACH REAGENT CONTAINER CONTAINS AT LEAST THE VOLUME LISTED ON THE WORKLIST (PLUS AN ADDITIONAL 10% OF THE FULL VOLUME OF THE CONTAINER TO ACCOUNT FOR DEAD VOLUME). " A NOTIFICATION HIGHLIGHTING THIS VERIFICATION TASK WAS ISSUED BY BECKMAN COULTER INC. TO THE CUSTOMER WITH CONFIRMED RECEIPT ON (B)(4) 2011

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHOLE BLOOD SAMPLES WERE STAINED WITH CD45-ECD, AN ANALYTE SPECIFIC REAGENT, AND WERE USED IN A PANEL TO OBTAIN WHITE BLOOD CELL (WBC) DIFFERENTIAL BY FLOW CYTOMETRY ON A PREPPLUS 2 INSTRUMENT. SAMPLES THAT DID NOT CONTAIN THE ANTIBODY REAGENT SHOWED UNEXPECTED RESULTS IN ALL GATES OF THE CD45-ECD VS SS LOG HISTOGRAM RESULTS. THE CUSTOMER IDENTIFIED THAT THE REAGENT BOTTLE WAS EMPTY BUT THE SENSOR DID NOT ALERT THE CUSTOMER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND HENCE NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED OR ATTRIBUTED TO THIS EVENT. UPON REVIEW THE SUSPECT DATA WAS IDENTIFIED AND THE SAMPLES WERE MANUALLY PIPETTED AND REPROCESSED. THE CORRECT RESULTS WERE REPORTED. INSTRUMENT QUALITY CONTROL RESULTS BEFORE AND AFTER THE INCIDENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPPLUS 2 STATION, PIPETTING AND DILUTING JQW BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1