BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK7300 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 1920396 · Received December 10, 2010

    Report

    Report Number
    2050012-2010-01662
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    KSZ
    PMA / PMN Number
    BK060024
    Removal / Correction Number
    2050012-12/10/2010-045C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE ON BD TUBES WITH A 10 MINUTE SPIN TIME AND THEN IMMEDIATE RUN ON THE INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THE CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE LOOSE AND TIGHTENED IT AND TIGHTENED FITTINGS ON THE REAGENT SYRINGE.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE AND CORRECTIVE ACTION ARE UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A DRIPPING REAGENT PROBE ON THE PK7300 AUTOMATED MICROPLATE SYSTEM. NO PATIENTS WERE INVOLVED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER HAD A LOOSE CC SAMPLE SYRINGE WHICH CAUSED 3 ERRONEOUSLY HIGH PHOSPHORUS RESULTS. THE SPECIFIC RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7300 AUTOMATED MICROPLATE SYSTEM AUTOMATED MICROPLATE SYSTEM KSZ BECKMAN COULTER MISHIMA K.K. PK7300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1