BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1071751 · Received July 9, 2008

    Report

    Report Number
    2122870-2008-00218
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS PLASMA SAMPLES IN PLASTIC GREINER TUBES WITH GEL. PT'S TWO SAMPLE WAS SAMPLED FROM THE PRIMARY TUBE AND CENTRIFUGED FOR 5 MINUTES AT 3500 RPM. QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT ON (B) (6) 2008. A SYSTEM CHECK PERFORMED ON (B) (6) 2008 AT 4:48 AM RESULTED WITHIN SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG. CUSTOMER TECHNICAL SERVICE (CTS) HAD THE CUSTOMER PERFORM THE PIPETTOR MATCHING PROCEDURE ON (B) (6) 2008 AT APPROX 9:00 AM WHICH MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE ON (B) (6) 2008 AND VERBALLY SUPPLIED DATA: FSE PERFORMED SERVICE PROTOCOL TO INCLUDE SYSTEM CHECK, DIAGNOSTIC TESTING AND ALIGNMENT CHECKS. ALL TESTING MET SPECIFICATIONS. FSE ALSO STATED THAT THE CUSTOMER BELIEVED THE EVENT FOR PT ONE WAS DUE TO THE PT SAMPLE AND WANTED SERVICE TO VERIFY THE INSTRUMENT REGARDLESS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PTS. CUSTOMER TESTED A PT SAMPLE FOR ACCUTNI AND OBTAINED RESULTS IN THE RANGE OF 0.48-1.23 NG/ML. UPON ANALYSIS ON A DIFFERENT INSTRUMENT, RESULTS OF 0.26 AND 0.35 NG/ML WERE OBTAINED. ANOTHER SAMPLE OBTAINED FROM THIS PT WHEN TESTED GAVE RESULTS IN THE RANGE OF 0.48- 0.88NG/ML AND UPON REPEAT ON A DIFFERENT INSTRUMENT GAVE RESULTS IN THE RANGE OF 0.18-0.24NG/ML. A SAMPLE OBTAINED FROM ANOTHER PT WHEN TESTED GAVE RESULTS OF 0.60NG/ML AND "<0.10NG/ML" AND UPON REPEAT ON A DIFFERENT INSTRUMENT, IT AGAIN GAVE A RESULT OF "0.010NG/ML". ERRONEOUS RESULTS FOR PT 1 WERE NOT REPORTED OUTSIDE THE LAB AND IT IS UNCLEAR WHETHER THE ERRONEOUS RESULT FOR PT 2 WAS REPORTED OUTSIDE THE LAB. THE CUSTOMER DID NOT REPORT PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA