BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2874572 · Received December 15, 2012

    Report

    Report Number
    2050012-2012-01923
    Event Type
    Injury
    Date Received
    December 15, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: CUSTOMER DID NOT REQUEST ON-SITE SERVICE FROM BEC. CONCLUSION: BEC EVALUATION OF THE EVENT AND THE DATA PROVIDED BY THE CUSTOMER INDICATES THERE IS NO EVIDENCE OF A SYSTEM MALFUNCTION. THE ISSUE WAS ISOLATED TO ONE PATIENT SAMPLE. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES. CUSTOMER REPORTED THEY REVIEWED OTHER CREATININE RESULTS FROM THE SAME TIME AND COULD FIND NO EVIDENCE OF OTHER SAMPLES WITH QUESTIONABLE RESULTS. SUBSEQUENT TESTING CONFIRMED ABNORMALLY HIGH RECOVERY WITH BOTH THE DXC 800 AND AN ALTERNATE METHODOLOGY. THE CUSTOMER DID NOT AMEND THE RESULT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT ON (B)(6) 2012, THE UNICEL DXC 800 SYNCHRON SYSTEM (DXC 800) GENERATED A CREATININE (CREM) RESULT OF 9.55 MG/DL ON A (B)(6) MALE PATIENT WITH STAGE 2 CHRONIC KIDNEY DISEASE. THE RESULT OF 9.55 MG/DL WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL ON (B)(6) 2012 BASED ON THE 9.55 MG/DL RESULT. CUSTOMER REPORTED THE ADMITTING HOSPITAL'S ANALYZER RETURNED A LOW CREATININE RESULT, 1.04 MG/DL. CUSTOMER REPORTED THE PATIENT WAS ADMITTED BASED ON THE HIGH CREATININE RESULT BUT TREATMENT WAS NOT AFFECTED DUE TO THE LOW RETEST RESULT. CUSTOMER REPORTED THAT ON (B)(6) 2012, THEY RERAN THE PATIENT'S SAVED REFRIGERATED SAMPLE COLLECTED ON (B)(6) 2012 ON THE DXC 800 AFTER THE DOCTOR REPORTED THE DISCREPANCY IN RESULTS. THE DXC 800 GAVE A SUPPRESSED RESULT. CUSTOMER REPORTED THEY THEN DILUTED THE SAMPLE 1:2. THE DXC 800 GAVE A RESULT OF 35.7 MG/DL FOR THE DILUTED SAMPLE. CUSTOMER REPORTED THAT THEY SENT THE SAVED REFRIGERATED SAMPLE COLLECTED ON (B)(6) 2012 TO ANOTHER LABORATORY ON (B)(6) 2012 FOR RETEST. CUSTOMER REPORTED THE ROCHE ANALYZER AT THE OTHER LABORATORY YIELDED A RESULT OF 35 MG/DL. CUSTOMER REPORTED SINCE THE RETEST RESULTS WERE ABNORMALLY HIGH ALONG WITH THE ORIGINAL 9.55 MG/DL RESULT, THEY DECIDED NOT TO AMEND THE 9.55 MG/DL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other