BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2311945 · Received October 27, 2011

    Report

    Report Number
    2122870-2011-05005
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 27, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHS
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE COLLECTED IN SERUM TUBES, AND WERE CENTRIFUGED FOR 5 MINUTES AT 5607 RPM. THE SAMPLES WERE NOT RE-CENTRIFUGED PRIOR TO REPEAT TESTING. QC WAS PERFORMING WITHIN THE ESTABLISHED LIMITS ON THE DATE OF THE EVENT. A SYSTEM CHECK PERFORMED BY THE CUSTOMER ON (B)(4) 2011 PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. THE CUSTOMER REPORTED THERE WAS A WASH VALVE/PUMP MOTION ERROR MESSAGE IN THE INSTRUMENT EVENT LOG. SERVICE WAS ON SITE ON THE DATE OF THE EVENT, (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A CRACK IN THE WASH PUMP HOME SENSOR. THE FSE REPLACED THE WASH PUMP HOME SENSOR AND RESEATED THE WASH PUMP FLAG. THE FSE PERFORMED A 20 REPLICATE LOW LEVEL ACCUTNI PRECISION RUN WITH ACCEPTABLE BUT SLIGHTLY ERRATIC RESULTS. THE FSE OBSERVED BUILD UP ON THE TRANSDUCER AND AFTER CLEANING THE TRANSDUCER AND PERFORMING A SECOND PRECISION RUN WITH QUESTIONABLE RESULTS, THE FSE ORDERED A REPLACEMENT TRANSDUCER FOR INSTALLATION AT A LATER DATE. THE FSE RETURNED TO THE CUSTOMER SITE ON (B)(4) 2011, AND REPLACED THE TRANSDUCER. THE FSE PERFORMED A PRECISION RUN TO VERIFY HARDWARE. THE ACCUTNI PRECISION RUNS USING LOW LEVEL AND HIGH LEVEL ACCUTNI QC BOTH PRODUCED RESULTS WITHIN THE ESTABLISHED QC RANGES AND WITHIN THE PUBLISHED ASSAY PRECISION CLAIMS. ALTHOUGH HARDWARE REPAIRS WERE REQUIRED AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE RELATED EVENTS ARE REPORTED IN THE BELOW LISTED MEDWATCH REPORTS: 2122870-2011-04743, 2122870-2011-04733, 2122870-2011-05007.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ACCESS 2 IMMUNOASSAY SYSTEM GENERATED ERRONEOUSLY ELEVATED CKMB RESULTS, ABOVE THE NORMAL REFERENCE RANGE, ON TWO PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JHS BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1