BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1033186 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00130
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER ARCHIVE DATA, QC WAS NOT PERFORMED ON THE DATE OF THE EVENT. A SYSTEM CHECK PERFORMED PRIOR TO THE EVENT, IN 2008, MET SPECIFICATIONS. THE ISSUE WAS ISOLATED TO THE TWO PT SAMPLES AND THE QUESTIONABLE RESULTS OCCURRED FROM THE SAME REAGENT PACK. NO ERRORS WERE POSTED TO THE EVENT LOG AT THE TIME OF THIS EVENT. THE SPECIMENS WERE COLLECTED. PER CUSTOMER, THE SAMPLES WERE FULL DRAWS AND WERE INVERTED PER THE TUBE MANUFACTURER'S RECOMMENDATIONS AT THE TIME OF COLLECTION. THE SPECIMENS WERE CENTRIFUGED. ALL SAMPLING WAS DONE FROM THE PRIMARY TUBES AND THE CORRECT RACK/TUBE COMBINATION WAS USED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND NOTED THAT THE SUBSTRATE LINE HAD BEEN CUT. AS A RESULT, THE TUBING LENGTH WAS SHORTENED AND CONTAINED A KINK. PER FSE, THE KINKED TUBING COULD CAUSE MICRO BUBBLES AND IS THE LIKELY CAUSE OF THIS EVENT. THE FSE SERVED AND VERIFIED THE INSTRUMENT. THE FSE COMMUNICATED HIS OBSERVATION TO THE SUPERVISOR. ALTHOUGH THE FSE OBSERVED THE KINKED TUBING, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING ELEVATED TROPONIN (ACCU TNI) RESULTS GENERATED BY THE ACCESS 2 INSTRUMENT FOR TWO PTS. PT A: A SAMPLE FROM THIS PT GAVE A RESULT OF 0.58NG/ML. THE SAMPLE WAS RETESTED AND REPEATED RESULT WAS 1.24 NG/ML. THE SPECIMEN WAS RE-CENTRIFUGED AND A RESULT OF 0.06NG/ML WAS OBTAINED. ADDITIONALLY, THE RE-CENTRIFUGED SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND AN ACCU TNI RESULT WAS 0.09NG/ML. PT B: A SAMPLE FROM THIS PT WAS TESTED FOR ACCU TNI AND AN INITIAL RESULT WAS 0.55NG/ML AND 0.31NG/ML UPON REPEAT. THE SPECIMEN WAS RE-CENTRIFUGED AND A RESULT OF 0.29NG/ML WAS OBTAINED. THE RE-CENTRIFUGED SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND AN ACCU TNI RESULT WAS 0.27 NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT OCCURRED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA