BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3853530 · Received June 6, 2014

    Report

    Report Number
    9612296-2014-00087
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K112412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE IMPRECISION ISSUES NOTED ON CALCIUM. QC WAS RUNNING HIGH, BUT PATIENT RESULTS WERE LOW. FSE REVIEWED REAGENT BLANK AND CALIBRATION HISTORY. THIS REVIEW IDENTIFIED SEVERAL "SPIKES" IN CALIBRATION FACTOR RECOVERY AND "DROPS" IN QC RECOVERY. THIS DATA WAS COMPARED WITH THE OTHER AU5800 IN THIS LAB. NO ISSUES WERE NOTED ON THE OTHER ANALYZER. ISSUE ISOLATED TO SINGLE INSTRUMENT. CUSTOMER HAS SAME LOT ON BOTH ANALYZERS. CALCIUM REAGENT ELIMINATED AS A CAUSE. THE FSE PROPERLY SEATED ALL REAGENTS. R1 REAGENT PROBE WAS REPLACED AND RE-ALIGNED. IMPROPERLY SEATED REAGENTS ARE LIKELY TO BE CAUSE OF THE R1 PROBE ISSUES AS WELL AS THE CAUSE OF ALARM CODE 3607 GENERATED BY THE SYSTEM. FSE REPLACED BENT SAMPLE PROBE, BENT MIX BAR, R1 SYRINGES, SAMPLE SYRINGES, AND LAMP. FSE VERIFIED R1 AND R2 MIX UNIT ALIGNMENTS, CUVETTE WASH UNIT ALIGNMENT, AND SAMPLE PROBES (INNER AND OUTER) ALIGNMENTS. FSE DOUBLE CHECKED THE R1-INNER REAGENT PROBE ALIGNMENT FOR ALL LOCATIONS. THE FSE PERFORMED PHOTOCAL WITH ACCEPTABLE RECOVERY. FSE PRIMED THE SYSTEM AND OBSERVED NO ERRORS OR EVIDENCE OF LEAKING ON ANY SYRINGES. FSE PERFORMED CALCIUM CALIBRATION AND QC WITH ACCEPTABLE RECOVERY. PRECISION TESTING (N=20) WAS PERFORMED ON CALCIUM. %CV = 0.65; ACCEPTABLE PRECISION RECOVERY <3.0%. THE MEAN VALUE FROM THE PRECISION TEST = <2 SD BASED ON CUSTOMERS QC RANGES. SYSTEM PERFORMANCE WAS VALIDATED TO BE MEETING SPECIFICATIONS. THIS ISSUE WAS AN ON-GOING ISSUE WITH TWO ADDITIONAL EVENTS REPORTED BY THE CUSTOMER. ON (B)(4) 2014 THE FSE DETERMINED THE CAUSE WAS DUE TO INNER SAMPLE PROBE VALVE FAILURE ALONG WITH MULTIPLE CONSUMABLE PARTS THAT WERE REPLACED AND ALIGNMENTS/ADJUSTMENTS PERFORMED. THIS MDR IS RELATED TO THE FOLLOWING MDRS FOR THE SAME ISSUE, OCCURRING ON DIFFERENT DATES: 9612296-2014-00086; 9612296-2014-00088.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ERRONEOUS CALCIUM TEST RESULTS WERE OBTAINED WHEN USING THE AU5800 CLINICAL CHEMISTRY ANALYZER ON (B)(6) 2014. ON (B)(6) 2014, THE CUSTOMER REPORTED ADDITIONAL ISSUES WITH CALCIUM TEST RESULTS. THE QUALITY CONTROL (QC) WAS REPORTED TO BE HIGH. THE CUSTOMER REPLACED THE REAGENT AND CALIBRATOR, AND REPEATED THE QC AND OBTAINED ACCEPTABLE RESULTS. THE PATIENT RUN WAS FOLLOWED BY SECOND QC RUN. QC FOR CALCIUM OUT HIGH, WITH LEVEL 1 = 9.0 MG/DL (MEAN 5.1) AND LEVEL 2 = 13.0 MG/DL (MEAN = 9.2). CUSTOMER REQUESTED IMMEDIATE RETURN OF SERVICE. CUSTOMER DISABLED THE ASSAY AND CONTINUED RUNNING THE OTHER TESTS ON THE SYSTEM. CUSTOMER CONFIRMED NO ERRONEOUS RESULTS WERE REPORTED OUT FOR THIS EVENT. NO AFFECT TO PATIENT TREATMENT. NO DEATH OR INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331289 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5811-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1