BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2131811 · Received June 16, 2011

    Report

    Report Number
    2122870-2011-01844
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED AND MULTIPLE VISUAL AND PERFORMANCE VERIFICATION ASSESSMENTS WERE CONDUCTED. THE FIELD SERVICE ENGINEER PERFORMED A SYSTEM CHECK WHICH MET ESTABLISHED SPECIFICATION. A HSINC52 PERFORMANCE TEST WAS EXECUTED WHICH ASSESSED REACTION VESSEL MOVEMENT THROUGH THE INCUBATOR TRACK (INCUBATION) TO DETECT SPLASHING. A "HSLUMWASHSON" PERFORMANCE TEST WAS ALSO EXECUTED WHICH ASSESSED THE WASTE SYSTEM (ASPIRATION). BOTH ASSESSMENTS MET ESTABLISHED SPECIFICATIONS. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING IS A LIKELY ROOT CAUSE TO THIS EVENT, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUS, HIGH CARDIAC TROPONIN (ACCUTNI) RESULT WAS GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE, EMERGENCY ROOM PATIENT. THE INITIAL, ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS ADMINISTERED PLAVIX AND WARFARIN. TWO SUBSEQUENT PATIENT REDRAWS, GENERATED ON THE SAME INSTRUMENT, RESULTED IN LOWER ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE, THAT WERE CONSIDERED VALID AND REPORTED OUT OF THE LABORATORY. AT THIS TIME THE LABORATORY QUESTIONED THE INITIAL RESULT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN AND SHORTNESS OF BREATH. THE CUSTOMER INDICATED THAT THE PATIENT DIED SOME TIME LATER. THE CUSTOMER'S PATIENT QUALITY COORDINATOR INDICATED THAT SHE DID NOT BELIEVE THAT THE PATIENT'S DEATH OR TREATMENT REGIMENT WAS IMPACTED, ASSOCIATED OR ATTRIBUTABLE TO THE ERRONEOUS ACCUTNI RESULT. THE INITIAL SAMPLE WAS A VERY SHORT DRAW, WITHOUT ENOUGH PLASMA TO REPEAT IT. THE CUSTOMER PATIENT QUALITY COORDINATOR CONFIRMED THE INITIAL DRAW WAS SUSPECT FOR FIBRIN INTERFERENCE. ATTEMPTS TO RETEST THE INITIAL SAMPLE WERE MADE BY MAKING DILUTIONS. DETAILS OF HOW THE DILUTIONS WERE MADE WAS NOT PROVIDED BY THE CUSTOMER. THE PATIENT HAD A B-TYPE NATRIURETIC PEPTIDE (BNP) RESULT OF >2000 PG/ML FROM A DIFFERENT SAMPLE, DRAWN AND RUN AT THE SAME TIME AS THE INITIAL, ERRONEOUS ACCUTNI RESULT. SUBSEQUENT PATIENT BNP AND COMPLETE BLOOD COUNT (CBC) RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RESULTS PRIOR TO THE EVENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. THERE WERE NO SYSTEM EVENT LOG MESSAGES GENERATED DURING THE EVENT TIMEFRAME. NO SYSTEM DATA WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED NO ISSUES WITH OTHER ASSAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ACCESS ACCUTNI REAGENT