BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2188347 · Received July 29, 2011

    Report

    Report Number
    2050012-2011-03791
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUESTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT YET BEEN DETERMINED TO DATE, ALTHOUGH THIS EVENT APPEARS TO BE CONNECTED TO PERFORMING THE WEEKLY AUTOMATED FLOW CELL MAINTENANCE PROCEDURE. THE CUSTOMER HAS BEEN PROVIDED WITH AN ALTERNATE VALIDATED FLOW CELL MAINTENANCE PROCEDURE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 96 OF 120 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: 2050012-2011-03449, 2050012-2011-03450, 2050012-2011-03451, 2050012-2011-03452, 2050012-2011-03453, 2050012-2011-03454, 2050012-2011-03455, 2050012-2011-03456, 2050012-2011-03457, 2050012-2011-03458, 2050012-2011-03459, 2050012-2011-03460, 2050012-2011-03461, 2050012-2011-03462, 2050012-2011-03463, 2050012-2011-03601, 2050012-2011-03602, 2050012-2011-03603, 2050012-2011-03608, 2050012-2011-03610, 2050012-2011-03611, 2050012-2011-03612, 2050012-2011-03613, 2050012-2011-03614, 2050012-2011-03618, 2050012-2011-03621, 2050012-2011-03623, 2050012-2011-03624, 2050012-2011-03633, 2050012-2011-03634, 2050012-2011-03635, 2050012-2011-03636, 2050012-2011-03640, 2050012-2011-03641, 2050012-2011-03642, 2050012-2011-03643, 2050012-2011-03644, 2050012-2011-03645, 2050012-2011-03658, 2050012-2011-03663, 2050012-2011-03664, 2050012-2011-03668, 2050012-2011-03670, 2050012-2011-03682, 2050012-2011-03683, 2050012-2011-03691, 2050012-2011-03692, 2050012-2011-03693, 2050012-2011-03694, 2050012-2011-03695, 2050012-2011-03696, 2050012-2011-03697, 2050012-2011-03698, 2050012-2011-03699, 2050012-2011-03700, 2050012-2011-03701, 2050012-2011-03702, 2050012-2011-03703, 2050012-2011-03704, 2050012-2011-03705, 2050012-2011-03706, 2050012-2011-03707, 2050012-2011-03708, 2050012-2011-03709, 2050012-2011-03710, 2050012-2011-03718, 2050012-2011-03719, 2050012-2011-03720, 2050012-2011-03721, 2050012-2011-03722, 2050012-2011-03723, 2050012-2011-03724, 2050012-2011-03725, 2050012-2011-03726, 2050012-2011-03757, 2050012-2011-03760, 2050012-2011-03762, 2050012-2011-03765, 2050012-2011-03766, 2050012-2011-03767, 2050012-2011-03768, 2050012-2011-03769, 2050012-2011-03770, 2050012-2011-03771, 2050012-2011-03772, 2050012-2011-03777, 2050012-2011-03783, 2050012-2011-03784, 2050012-2011-03785, 2050012-2011-03786, 2050012-2011-03787, 2050012-2011-03788, 2050012-2011-03789, 2050012-2011-03790, 2050012-2011-03792, 2050012-2011-03793, 2050012-2011-03795, 2050012-2011-03796, 2050012-2011-03798, 2050012-2011-03799, 2050012-2011-03800, 2050012-2011-03801, 2050012-2011-03802, 2050012-2011-03803, 2050012-2011-03804, 2050012-2011-03805, 2050012-2011-03806, 2050012-2011-03807, 2050012-2011-03808, 2050012-2011-03809, 2050012-2011-03810, 2050012-2011-03811, 2050012-2011-03812, 2050012-2011-03813, 2050012-2011-03814, 2050012-2011-03815, 2050012-2011-03816, 2050012-2011-03817.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT AFTER PERFORMING WEEKLY AUTOMATED FLOW CELL MAINTENANCE ON THEIR UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM, THE SYSTEM PROVIDED ERRONEOUSLY LOW RESULTS FOR SODIUM (NA) AND CHLORIDE (CL) FOR APPROXIMATELY 120 PT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. IT IS UNK IF THERE WERE ANY CHANGES TO PT TREATMENT AS A RESULT OF THIS EVENT. THERE ARE NO REPORTS OF DEATH OR SERIOUS INJURY RELATED TO THIS EVENT. THIS IS REPORT 96 OF 120 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PT 94 OF 120 PTS. THE CUSTOMER STATED THAT THE BIO-RAD QUALITY CONTROL (QC) DID NOT SHOW THESE LOW RESULTS. THE CUSTOMER STATED THAT AFTER PERFORMING THE MAINTENANCE, THEY RAN PT SAMPLES ALL DAY AND HAD A COUPLE OF CRITICAL LOW SODIUM RESULTS. THE CUSTOMER THEN RECALIBRATED THE SYSTEM AND RE-RAN THE CRITICAL LOW RESULTS, FINDING THAT THE SODIUM RESULTS HAD INCREASED BY APPROXIMATELY 10 MMOL AND THE CHLORIDE RESULTS HAD INCREASED BY APPROXIMATELY 7 MMOL. THE CUSTOMER THEN RE-RAN THE ENTIRE DAY'S RESULT, FINDING THAT SODIUM INCREASED BY 7 - 10 MMOL AND CHLORIDE BY 4 - 5 MMOL. THE CUSTOMER STATED THAT ALL PT RECORDS WERE UPDATED WITH THE RE-RUN RESULTS. THE CUSTOMER STATED THAT THESE LOW SAMPLE RESULTS BEGAN TO OCCUR WHEN HE STARTED USING THE NEW VERSION 2.0 AUTOMATED MAINTENANCE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE REFERENCE| ISE ELECTROLYTE BUFFER