BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2365244 · Received December 9, 2011

    Report

    Report Number
    2122870-2011-06366
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K974075
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 IN CONJUNCTION WITH THIS EVENT. ON (B)(4) 2011 A FIELD SERVICE ENGINEER (FSE) PERFORMED A PM UPON ARRIVAL AT THE CUSTOMER SITE. THE FSE DETECTED THE PRECISION PUMP SEAL WAS LEAKING AND REQUIRED REPAIRS DURING THE PM. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO HOTLINE THAT THE ACCESS 2 IMMUNOASSAY SYSTEM GENERATED ERRATIC LOW LEVEL ACCUTNI QC RESULT. THE CUSTOMER REPORTED THAT QC WAS IMPRECISE WITH SOME FLIERS OUTSIDE OF THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER DID NOT REPORT ANY ERRONEOUS OR QUESTIONABLE PATIENT RESULTS OR SAMPLES BEING EFFECTED IN CONNECTION TO THIS EVENT. THE CUSTOMER REPORTED ERRATIC LEVEL 1 ACCUTNI QC PERFORMANCE. THE CUSTOMER PERFORMED A PASSING SYSTEM CHECK ON (B)(6) 2011 WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER THEN PERFORMED 10 ACCUTNI TESTS WITH LEVEL 1 QC MATERIAL AND THE CUSTOMER OBTAINED A TEN RESULTS WITH A % CV OF 36.6 %, HOTLINE THEN SUGGESTED THE CUSTOMER QUITS USING THE INSTRUMENT UNTIL SERVICE CAN EVALUATE AND VERIFY HARDWARE HOTLINE BEGAN TROUBLE SHOOTING THE EVENT WITH THE CUSTOMER AND IT WAS DETERMINED THAT ACCUTNI LOW LEVEL QC PRECISION WAS NOT MEETING LABELED ACCUTNI ASSAY PRECISION CLAIMS SO ON SITE SERVICE WAS DISPATCHED TO VERIFY HARDWARE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1