BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL BDS SAMPLE SET

    MDR report key: 537673 · Received March 23, 2004

    Report

    Report Number
    2432733-2004-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    February 20, 2004
    Report Date
    February 24, 2004
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    MZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN A NON-CLINICAL SETTING, ONE(1) OF TWO(2) DEVICES UNDERGOING PROCESS VALIDATION TESTING AT A USER FACILITY GAVE UNEXPECTED READINGS WHICH LED TO AN ERRONEOUS CONCLUSION ABOUT THE SAMPLE BEING TESTED (FALSE NEGATIVE FOR BACTERIAL CONTAMINATION), DURING QC EVALUATION OF BB PROCESSES. WHEN THE TWO(2) INSTRUMENTS THAT WERE USED FOR VALIDATION TESTING AGAIN THE NEXT DAY, AFTER REPLACEMENT OF THE DISPOSABLE SAMPLING TUBE ASSEMBLIES, BOTH INSTRUMENTS GAVE COMPARABLE EXPECTED READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BDS SAMPLE SET BACTERIA DETECTION SYSTEM MZC PALL BIOMEDICAL PRODUCTS CO. BDS 02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *