BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE)

    MDR report key: 2951166 · Received February 8, 2013

    Report

    Report Number
    9612296-2013-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    BEC CTS EXPLAINED THAT THE GEL FROM THE OLD SAMPLE PROBE MAY HAVE BEEN TRANSFERRED INTO THE ISE FLOWCELL. THE CUSTOMER FLUSHED THE ISE. ISE APPEARED TO HAVE BEEN RUNNING ACCEPTABLY AFTER THE FLUSH AND CONTINUED TO RUN THE INSTRUMENT. THE CUSTOMER STATED THAT THEY WERE NOT SEEING ANY ISSUES WITH CALIBRATION SLOPES OR QC WITH THE ISE SYSTEM. THE ELECTRODES WERE ONLY THREE WEEKS OLD AND ALL MAINTENANCE WAS UP TO DATE. A BEC SERVICE REQUEST WAS INITIATED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE OBSERVED AIR BUBBLES BETWEEN THE ISE REFERENCE VALVE AND FLOWCELL. THE FSE DETERMINED THAT THE ISE REFERENCE VALVE WAS BAD, SO THE FSE REPLACED IT. THE ISES WERE CALIBRATED AND QC WAS RUN, ALL PERFORMED WITHIN SPECIFICATIONS. NO ISE ISSUES OR RESULT PROBLEMS WERE NOTED. A BEC APPLICATION SPECIALIST WAS ON SITE TO CONDUCT CUSTOMER TRAINING ON THE ANALYZER. NO FURTHER K ISSUES HAVE BEEN REPORTED. MDR 9612296-2013-00014 IS ASSOCIATED WITH THIS REPORT. THIS MDR DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRONEOUS POTASSIUM (K) PATIENT RESULTS GENERATED ON THE AU681-10E CHEMISTRY ANALYZER OVER THE COURSE OF TWO (2) DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013. THE CUSTOMER INITIALLY INDICATED THAT THE SAMPLE PROBE MAY HAVE BEEN CONTAMINATED WITH GEL FROM A SERUM SEPARATOR TUBE. BEC CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO REPLACE THE PROBE. AFTER THE PROBE WAS REPLACED, THE CUSTOMER STATED THAT THEY OBTAINED ERRONEOUS K RESULTS. TWO (2) OF THE FOUR (4) ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE FIRST PATIENT RESULT OF 2.4 MMOL/L REPORTED OUT OF THE LABORATORY WAS AMENDED WITHIN AN HOUR. THE SECOND PATIENT RESULT REPORTED OUT OF THE LABORATORY OF 8.2 MMOL/L WAS SENT TO THE ER WHERE ANOTHER BLOOD SAMPLE WAS DRAWN AND TESTED FOR POTASSIUM. THE SECOND RESULT OF 3.2 MMOL/L (SLIGHTLY LOWER THAN THE NORMAL REFERENCE RANGE OF 3.5 - 5.1 MMOL/L) WAS CONSIDERED CORRECT AND RESULTED IN THE PATIENT TREATMENT, WHICH INCLUDED POTASSIUM PILLS, AN UNSPECIFIED INJECTION, TESTING FOR CARDIAC MARKERS, AND AN EKG. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. ALTHOUGH TREATMENT WAS NOT INITIATED UNTIL AFTER THE SECOND POTASSIUM RESULT WAS OBTAINED IN THE ER, THE DELAY OF TREATMENT IN THIS CASE WAS NOT CLINICALLY SIGNIFICANT, GIVEN THAT THE PATIENT'S POTASSIUM LEVEL WAS JUST BELOW THE NORMAL REFERENCE RANGE AND THUS DID NOT PRESENT A MEDICALLY URGENT CONDITION. AS A RESULT, BECKMAN COULTER HAS CONCLUDED THAT THERE WAS NO ADVERSE EVENT AND THIS MDR REPORT IS BASED UPON A REPORTABLE MALFUNCTION RELATED TO THE INITIAL FALSELY ELEVATED POTASSIUM RESULT. THE CUSTOMER REPORTED THAT THERE IS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53578 AU681-10E CLINICAL CHEMISTRY ANALYZER (WITH ISE) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER AU681-10E (WITH ISE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR