BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER TQ-PREP WORKSTATION

    MDR report key: 5088649 · Received September 18, 2015

    Report

    Report Number
    1061932-2015-01480
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    PER
    PMA / PMN Number
    K130253
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED THAT THE SAMPLE TUBE DID NOT HAVE THE CORRECT AMOUNT OF REAGENT WHEN THE SAMPLE WAS PREP ON THE TQ PREP INSTRUMENT. THE SAMPLE LINE HAD ASPIRATED AIR SINCE THE REAGENT BOTTLES WERE EMPTY. THERE WAS A FAILURE OF THE SENSORS. NO ERROR MESSAGE ALERTED THE CUSTOMER THAT THE REAGENT BOTTLES WERE EMPTY SINCE THE SENSORS HAD FAILED. THE FSE REPLACED BOTH REAGENT SENSORS TO RESOLVE THE ISSUE.(B)(4).

    Description of Event or Problem · 1

    THE FSE (FIELD SERVICE ENGINEER) REPORTED THAT THE REAGENT SENSORS (REAGENT A AND REAGENT B SENSORS) IN A COULTER TQ-PREP WORKSTATION FAILED AND DID NOT GENERATE THE LOW REAGENTS MESSAGES. THE CUSTOMER PERFORMS THE DAILY INSTRUMENT CHECK AS PER INSTRUCTIONS FOR USE AND THE CUSTOMER VISUALLY CONFIRMS THE TUBES AFTER PREPARATION, WHICH ALERTED THE CUSTOMER TO THE ISSUE. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619031 COULTER TQ-PREP WORKSTATION AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO PER BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1