BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER PROCESSOR CENTRIFUGE

    MDR report key: 2123308 · Received September 28, 2006

    Report

    Report Number
    2050012-2006-00023
    Event Type
    Other
    Date Received
    September 28, 2006
    Date of Event
    August 30, 2006
    Report Date
    September 28, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RUNS QC TWICE PER DAY AND QC RESULTS WERE WITHIN SPECIFICATIONS PRIOR TO THE EVENT. QC WAS NOT PERFORMED AFTER THE EVENT. THE SAMPLE WAS COLLECTED IN 5ML, PLASTIC, LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 3,000 RPM FOR 8 MINUTES. THE CUSTOMER INDICATED THAT THE EVENT OCCURRED JUST AFTER THE ROUTINE YEARLY POWER PROCESSOR CENTRIFUGE ROTOR REPLACEMENT. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S LAB. THE FSE PERFORMED NECESSARY ALIGNMENTS TO THE ROTOR AND TO THE CENTRIFUGE. THE FSE VERIFIED SPEED AND TIMER ON THE ROTOR AND THE CENTRIFUGE; BOTH WERE WORKING PER DESIGN. PER BECKMAN COULTER PRODUCT LABELING, THE ACCU TNI RESULT OBTAINED IN THIS EVENT WAS WITHIN THE RISK STRATIFICATION RANGE, AND WELL BELOW THE AMI CUT-OFF OF 0.50 NG/ML. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN EVENT WITH THE POWER PROCESSOR CENTRIFUGE. THE CUSTOMER INDICATED THAT A PATIENT SAMPLE WAS TESTED FOR TROPONIN (ACCU TNI) AND A RESULT OF 0.25 NG/ML WAS OBTAINED. THE SAMPLE WAS RE-TESTED AND THE REPEATED ACCU TNI RESULT WAS 0.05 NG/ML. THE CUSTOMER INDICATED THAT THE PATIENT WAS ADMITTED BASED ON THE ACCU TNI RESULT. HOWEVER, THERE WAS NO DEATH OR SERIOUS INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR CENTRIFUGE CLINICAL AUTOMATION JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other