BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2832717 · Received November 14, 2012

    Report

    Report Number
    2050012-2012-01853
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE ION SELECTIVE ELECTROLYTE (ISE) SYSTEM AND REPLACED THE SODIUM (NA) REFERENCE ELECTRODE. THE FSE INCIDENTALLY NOTED THE K ELECTRODE TIP WAS NOT SECURED IN PROPERLY AND CONTAINED AN EXTRA O-RING. THE FSE CORRECTED THE K ELECTRODE TIP ISSUE AND VERIFIED SYSTEM PERFORMANCE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. REVIEW OF PROSERVICE QUALITY CONTROL (QC) DATA SHOWS SODIUM (NA) QC DID EXHIBIT LOW RECOVERY PRIOR TO THE EVENT (CHLORIDE (CL) AND CALCIUM (CA) ALSO EXHIBITED LOW RECOVERY). THE CUSTOMER'S ESTABLISHED QC RANGES WERE WIDE AND BIASED LOW; AS A RESULT, QUALITY CONTROL DID NOT FLAG THE DISCREPANCY. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2050012-2012-01852, 2050012-2012-01853, 2050012-2012-01855.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS SODIUM (NA) RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. AN ERRONEOUS RESULT OF 124 MMOL/L WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE FALSE RESULT. IT IS UNKNOWN IF ANY TREATMENT WAS ADMINISTERED. AN AMENDED RESULT OF 133 MMOL/L WAS ISSUED TO THE PHYSICIAN UPON SAMPLE REANALYSIS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization