BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2114157 · Received June 6, 2011

    Report

    Report Number
    2122870-2011-01644
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS DATA GENERATED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED ALL HARDWARE OF THE SYSTEM. NO ISSUES WERE OBSERVED. QUALITY CONTROL INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUS TOTAL TRIIODOTHYRONINE (TOTAL T3) RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES OVER AN UNKNOWN PERIOD OF TIME ANALYZED USING THE ACCESS TOTAL T3 REAGENT ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR ANY REPORT OF CHANGE TO PATIENT TREATMENT THAT IS ATTRIBUTABLE TO THIS EVENT. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NUMBER OF PATIENT SAMPLES IMPACTED AND THE TIME PERIOD INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL T3 REAGENT