BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® PREPPLUS2

    MDR report key: 2490460 · Received March 13, 2012

    Report

    Report Number
    1061932-2012-00875
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQW
    PMA / PMN Number
    CLASSIEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT WITH PASSING RESULTS. DATA PROVIDED SHOWED AN ERRONEOUS RESULT FOR LYMPH COUNT AND ITS SUBSETS (CD19, CD8, CD4, AND CD3) BUT WAS NOT REPORTED OUTSIDE THE LABORATORY. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND NO ASPIRATION PROBLEM ON THE RETURNED UNIT (SERIAL NUMBER (B)(4)) ONLY THAT THE SCREW WAS TOO SHORT AT LEVEL OF INSULATOR BOX. THE SHORT SCREW DID NOT CONTRIBUTE TO THE REPORTED EVENT. THIS UNIT WAS LATER RETURNED TO THE CUSTOMER AND THEY HAVE SINCE NOT HAD ANY FLOW COUNT PROBLEMS. THE OCCASIONAL LEVEL SENSE ISSUE IN BOTH INSTRUMENTS AND THE BLOOD DETECTION ISSUE FOR THE LOANER INSTRUMENT ARE UNKNOWN AND ARE CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) STATING THAT TWO COULTER PREPPLUS2 INSTRUMENTS WERE DEMONSTRATING LEVEL SENSE ISSUES WHERE FLOW COUNT REAGENT WAS NOT BEING ASPIRATED. THE CUSTOMER STATED THAT BOTH OF THE INSTRUMENTS HAD FLOW COUNT ASPIRATION ISSUES AND THAT OCCASIONALLY THEIR PROBES WERE STOPPING OUTSIDE THE FLOW COUNT BOTTLE AND ASPIRATING AIR INSTEAD. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE ANALYZED ON THE CUSTOMER'S COULTER FC500 INSTRUMENT AND THE SAMPLES WERE INVALIDATED DURING THE SAMPLE ANALYSIS RUN. THERE WAS NO AFFECT TO PATIENTS. THIS REPORT DOCUMENTS THE SECOND PREP PLUS 2 INSTRUMENT (SERIAL NUMBER (B)(4)) WHICH WAS A LOANER INSTRUMENT FROM BEC TO THE CUSTOMER (WHILE THE PRIMARY UNIT WAS RETURNED TO BEC FOR SERVICING). PER CUSTOMER, THIS UNIT ALSO HAD PROBLEMS DETECTING BLOOD IN SPECIMEN TUBE IN ADDITION TO FLOW COUNT DETECTION. PREPPLUS2 SERIAL NUMBER (B)(4) WHICH WAS DEMONSTRATING LEVEL SENSE ISSUES WHERE FLOW COUNT REAGENT WAS NOT BEING ASPIRATED HAS BEEN DOCUMENTED IN A SEPARATE MDR REPORT (1061932-2012-00874).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® PREPPLUS2 PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE JQW BECKMAN COULTER INC. PREP PLUS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1