BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1200189 · Received September 24, 2008

    Report

    Report Number
    2122870-2008-00300
    Event Type
    Other
    Date Received
    September 24, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECK FROM 2008 SHOWS ALL PORTIONS WITHIN SPECIFICATIONS. THE CUSTOMER NOTICED THAT ALL THE 0.0 PG/ML RESULTS WERE OCCURRING TOWARDS THE END OF THE REAGENT PACKS. WHEN SPECIMENS WERE REPEATED ON NEW REAGENT PACKS RESULTS WOULD RECOVER HIGHER. THE CUSTOMER STARTED PULLING REAGENT PACKS WHEN THE COUNT GOT CLOSE TO 5 TESTS LEFT UNTIL SERVICE COULD BE ON-SITE FOR TROUBLESHOOTING. THE FIELD SERVICE ENGINEER (FSE) WAS ON-SITE IN 2008: FSE PERFORMED 50 REPS OF THE ASSAY FROM THE SAME PACK AND REPRODUCED THE ISSUE, THE CUSTOMER HAD NOTED. THE LAST THREE RESULTS DID REPORT 0.0 PG/ML. FSE, AT THE ADVICE OF CPLS (CUSTOMER PRODUCT LINE SUPPORT) INSPECTED THE PRECISION PUMP SPRING AND FOUND THAT IT WAS DEFECTIVE. HE REPLACED THE PUMP AND 50 REPS WERE REPEATED AND ALL REPS RESULTED AS EXPECTED. EVEN THOUGH INHIBIN A RESULTS ARE UNLIKELY TO BE THE BASIS TO INITIATE OR WITHHOLD TREATMENT, IN THIS EVENT, THE HARDWARE FAILURES COULD HAVE AFFECTED OTHER PIVOTAL ASSAYS. DUE TO A POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. 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 ERRONEOUS 0.0 PG/ML RESULTS FOR INHIBIN A GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ON FIVE PATIENTS' SAMPLES. THE INITIAL RESULTS ON ALL PATIENT SAMPLES WERE 0.0 PG/ML. THEY WERE ALL REPEATED AND REPEAT RESULTS WERE HIGHER; IN THE RANGE OF 133.5 - 196.8 PG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA