BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABX MINICLEAN

    MDR report key: 2920121 · Received January 9, 2013

    Report

    Report Number
    2086725-2013-00005
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    HORIBA ABX SAS
    Product Code
    LDT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MINICLEAN CONTAMINATION ISSUE IS A PART OF AN ON-GOING INVESTIGATION AT HORIBA MEDICAL. SUPPLEMENTAL REPORTS IN ACCORDANCE WITH 21 CFR 803.56 WILL BE SUBMITTED, AS NEEDED, WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO HORIBA MEDICAL (HORIBA) THAT THE ABX PENTRA 60 C+ HEMATOLOGY ANALYZER (PENTRA 60 C+) GENERATED HIGH PLATELETS ON THE CONTROL SAMPLES. CUSTOMER INDICATED THEY CLEANED THE T-FITTING AND PERFORMED CONCENTRATED CLEANING. CUSTOMER REPORTED THEY RAN A PRECISION TEST AND THE PLATELET BACKGROUND FAILED. THERE WAS NO ROOM OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. HORIBA FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE MINICLEAN BEING USED WAS CONTAMINATED. THE FSR DECONTAMINATED THE SYSTEM. THE FSR ALSO CONDUCTED GENERAL PREVENTIVE MAINTENANCE ON THE INSTRUMENT AND REPLACED THE RED BLOOD CELL CHAMBER, THE WHITE BLOOD CELL/HEMOGLOBIN CHAMBER AND THE SAMPLE PROBE, AS A PART OF THIS GENERAL PREVENTIVE MAINTENANCE. THE FSR PERFORMED SEVERAL BACKGROUND CHECKS. ALL THE BACKGROUNDS PASSED. THE FSR PERFORMED VALIDATION ON THE INSTRUMENT, CALIBRATED THE INSTRUMENT, AND RAN CONTROLS. ALL CONTROLS WERE WITHIN ESTABLISHED RANGES AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12841 ABX MINICLEAN GENERAL PURPOSE REAGENT LDT HORIBA ABX SAS 111013T1

    Patients

    Seq Age Sex Outcome Treatment
    1