BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 931860 · Received April 3, 2007

    Report

    Report Number
    2122870-2007-00081
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    March 13, 2007
    Report Date
    April 3, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. IN THE INITIAL RAN THE SPECIMEN WAS SAMPLED FROM AN INSERT CUP. IT IS UNCLEAR WHAT SAMPLE TYPE WAS USED BY THE CUSTOMER FOR DIG ANALYSIS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB IN 2007: THE FSE REPLACED: WASH, PRECISION AND SUBSTRATE PUMPS, DISPENSE PROBES, PIPETTOR TIP AND MIXERS. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURES. ALTHOUGH THE FSE ADDRESSED HARDWARE ISSUES, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY LOW DIGOXIN (DIG) RESULTS THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR DIG AND A RESULT OF 1.4NG/ML WAS OBTAINED. THE PRIMARY TUBE OF THE ORIGINAL SAMPLE WAS RE-CENTRIFUGED AND THEN THE SAMPLE WAS RE-TESTED FOR DIG; THE RESULT WAS 1.05NG/ML. THE RESULT OF 1.05NG/ML WAS REPORTED OUT OF THE LAB. ON THE SAME DAY, THE CUSTOMER TESTED THE ORIGINAL SAMPLE ON THE ABBOTT AXSYM SYSTEM FOR DIG AND OBTAINED 2 HIGHER RESULTS (2.36 AND 2.53). THE NEXT DAY, THE ORIGINAL SAMPLE WAS TESTED FOR DIG ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 2,83NG/ML WAS OBTAINED. THE CUSTOMER TESTED THE ORIGINAL SAMPLE FOR DIG ONCE MORE ON THE ACCESS 2 INSTRUMENT AND THE RESULT WAS 2.56NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA