BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3342022 · Received September 11, 2013

    Report

    Report Number
    2050012-2013-00597
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DKJ
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED BECKMAN COULTER WITH THREE (3) ORIGINAL SAMPLES FROM THE PATIENT FOR INVESTIGATION. BECKMAN COULTER NOTED THAT THE SAMPLES WERE VERY DARK ICTERIC-LOOKING IN COLOR. THE SAMPLES WERE RUN ON TWO DXC ANALYZERS AND PRODUCED SIMILAR RESULTS AS OBTAINED BY THE CUSTOMER FOR SALICYLATE (SALY) AND TOTAL BILIRUBIN (TBIL). BECKMAN COULTER HAS NOTIFIED THE CUSTOMER OF THE RESULTS. THE CUSTOMER DID NOT REQUEST FOR A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE INSTRUMENT SINCE THE RESULTS FOR SALY AND TBIL WERE DUPLICATED ON TWO DXC ANALYZERS. THE CUSTOMER PROVIDED BECKMAN COULTER WITH THE NON-BECKMAN COULTER INSTRUMENT'S INSTRUCTION FOR USE, AND A REVIEW INDICATED THAT THE METHODOLOGY AND CHEMICAL SEQUENCE, FOR BOTH THE DXC ANALYZER AND THE NON-BECKMAN COULTER INSTRUMENT, ARE THE SAME. THE PATIENT WAS STILL IN THE HOSPITAL ON (B)(6) 2013, EIGHT DAYS AFTER THE EVENT. THE PHYSICIAN WAS STILL ORDERING SALY TESTING TO MONITOR THE PATIENT ALTHOUGH THE CUSTOMER NOTIFIED THE PHYSICIAN AND THE CLINICAL PATHOLOGIST OF BECKMAN COULTER'S FINDINGS. THE SALY RESULTS CONTINUED TO BE HIGH AND THE TBIL RESULTS SUPPRESSED WITH OUT OF INSTRUMENT RANGE HIGH (OIRH) FLAGS, SIMILAR TO THE ORIGINAL RESULTS . THE CUSTOMER STATED THAT THE SAMPLES WERE NOT BEING SENT OUT FOR OTHER METHODOLOGY ANALYSIS AT THIS TIME. FAILURE MODE IS UNKNOWN AS THIS IS A SAMPLE-SPECIFIC EVENT. THE TBIL LEVEL IN THE SAMPLES TESTED WERE ABOVE THE INTERFERENCE CLAIM IN THE SALY CHEMISTRY INFORMATION SHEET LABELING. THE PHYSICIAN BELIEVED THE NON-BECKMAN COULTER INSTRUMENT'S LOWER SALY RESULTS BUT CONTINUED TO ORDER SALY TESTING ON THE DXC ANALYZER TO MONITOR THE PATIENT WHILE STILL IN THE HOSPITAL EIGHT DAYS LATER. THE NON-BECKMAN COULTER INSTRUMENT'S METHODOLOGY IS THE SAME AS THE DXC ANALYZER'S. PATIENT SAMPLES WERE ANALYZED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ONE HIGH SALICYLATE (SALY) PATIENT RESULT OF 3.0 MMOL/L FROM THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT THE SAMPLE ALSO HAD A VERY HIGH TOTAL BILIRUBIN (TBIL) LEVEL. THE INSTRUMENT GENERATED SUPPRESSED TBIL RESULTS FOR THE SAMPLE WITH OUT OF INSTRUMENT RANGE HIGH (OIRH) FLAGS. THE CUSTOMER REDREW SEVERAL SAMPLES FROM THE PATIENT AND SUBSEQUENT RUNS ON AN ALTERNATE DXC ANALYZER PRODUCED SIMILAR HIGH SALY RESULTS OF 3.0 TO 3.4 MMOL/L, AND SIMILAR SUPPRESSED TBIL RESULTS WITH OIRH FLAGS. THE CUSTOMER DILUTED THE SAMPLES AND CALCULATED THE TBIL RESULTS TO BE AROUND 976 UMOL/L. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT HEMODIALYSIS WHICH LATER CAUSED A RIGHT PLEURAL EFFUSION. THE PHYSICIAN ORDERED THE HEMODIALYSIS DUE TO THE HIGH SALY RESULTS. THE PATIENT WAS DIAGNOSED WITH (B)(6) AND PRESENTED THROUGH THE EMERGENCY ROOM FOR A POTENTIAL SALICYLATE OVERDOSE. THE CUSTOMER STATED THAT THE ORIGINAL SAMPLES WERE REPEATED ON A NON-BECKMAN COULTER INSTRUMENT IN ANOTHER HOSPITAL AND PRODUCED LOWER SALICYLATE RESULTS BELOW THAT INSTRUMENT'S ANALYTICAL MEASUREMENT RANGE. THE CUSTOMER DID NOT PROVIDE ANY DATA FOR THIS INSTRUMENT. THE CUSTOMER STATED THAT THE PHYSICIAN BELIEVED THE LOWER RESULTS. THE ANALYTICAL RANGE FOR SALY IS 0.3-7.2 MMOL/L AND TOXIC LEVEL IS CONSIDERED AT >2.2 MMOL/L. THE ANALYTICAL RANGE FOR TBIL IS 1.7-513 UMOL/L. THE CUSTOMER NOTED THAT ALL THE SAMPLES WERE SEVERELY ICTERIC AND THE WORST SEEN IN THE CUSTOMER'S LABORATORY. SALY CHEMISTRY INFORMATION SHEET NOTES AN INTERFERENCE CLAIM TESTING FOR TBIL UP TO 12 MG/DL (205.2 UMOL/L). THE UPPER ANALYTICAL RANGE FOR TBIL IS 513 UMOL/L AND THE SAMPLES TESTED WERE FLAGGED OUT OF INSTRUMENT RANGE HIGH ABOVE THIS LEVEL. THE CUSTOMER STATED THAT CALIBRATION AND QUALITY CONTROL (QC) RESULTS WERE WITHIN SPECIFICATIONS FOR BOTH DXC ANALYZERS PRIOR TO THE EVENT. THE CUSTOMER DREW SAMPLES FROM THE PATIENT FOLLOWING THE HEMODIALYSIS TREATMENT AND THE RUNS YIELDED SIMILAR SALY AND TBIL RESULTS AS THE SAMPLES DRAWN PRE-HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455161 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DKJ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other