BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2499197 · Received March 21, 2012

    Report

    Report Number
    2122870-2012-00835
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT SAMPLING DETAILS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. UPON REVIEW OF THE CUSTOMER SUPPLIED DATA, MULTIPLE QC FAILURES WERE OBSERVED SPORADICALLY DURING THE COURSE OF THIS EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. THE FSE PERFORMED ALL ALIGNMENTS AND VERIFICATIONS ON BOTH DXI INSTRUMENTS. THE FSE ALSO RAN MULTIPLE SYSTEM CHECKS AND QC WHICH ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. NO HARDWARE ISSUES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE FOLLOWING MDRS (TOTAL COUNT: 9) LISTED BELOW INCLUDES THE COMPLETE LIST OF REPORTS SUBMITTED FOR THIS EVENT THAT OCCURRED AT THIS CUSTOMER SITE: DXI 800 SERIAL # (B)(4) (SAME INSTRUMENT DOCUMENTED IN THIS REPORT); 2122870-2012-00834, 2122870-2012-00835, 2122870-2012-00836, 2122870-2012-00837; DXI 800 SERIAL # (B)(4); 2122870-2012-00838, 2122870-2012-00839, 2122870-2012-00840, 2122870-2012-00841, 2122870-2012-00842.

    Additional Manufacturer Narrative · 1

    (B)(4): AN ALIGNMENT OF THE REAGENT PIPETTORS PERFORMED BY BECKMAN COULTER INC. AS PART OF SERVICE FOR THIS EVENT PROVIDED AN IMPROVEMENT ON THE GI MONITOR REPRODUCIBILITY OVERALL, BUT IT WAS NOT THE ROOT CAUSE OF THE PROBLEM. BECKMAN COULTER INC. CUSTOMER TECHNICAL PRODUCT SUPPORT INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THIS EVENT AS CONTAMINATION OF THE TOP OF THE REAGENT PACKS CAUSED BY IMPROPER REAGENT HANDLING. THE CUSTOMER'S STAFF WAS GIVEN A REFRESHER TRAINING COURSE ON REAGENT PACK HANDLING AND THERE HAVE BEEN NO COMPLAINTS SINCE THAT TIME REGARDING THIS ISSUE. THE ROOT CAUSE OF THIS EVENT IS REAGENT PACK CONTAMINATION CAUSED BY USE ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING IMPRECISE GI MONITOR PATIENT RESULTS AND FAILING QUALITY CONTROL (QC) RESULTS THAT WERE GENERATED ON TWO (2) SEPARATE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMS (SERIAL #S (B)(4)), USED IN CONJUNCTION WITH TWO (2) ACCESS GI MONITOR REAGENTS (LOT #S 117293 AND 119635). THIS EVENT OCCURRED OVER THE COURSE OF SEVERAL DAYS, BETWEEN (B)(6) 2012. THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2012 ON THE DXI 800 INSTRUMENT SERIAL # (B)(4) AND USING THE GI MONITOR REAGENT LOT # 117293. THE IMPRECISE RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WAS NO DEATH OR INJURY TO PATIENT OR CHANGE IN TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS GI MONITOR REAGENT