BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1692359 · Received May 18, 2010

    Report

    Report Number
    1823260-2010-02982
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 20, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE FROM THE PATIENT WAS RETURNED FOR INVESTIGATION. THE RESULTS FROM THE ELECSYS WERE VERIFIED. DILUTION MEASUREMENTS CLEARLY IDENTIFIED AN INTERFERENCE IN THE SAMPLE. FURTHER INVESTIGATION COULD NOT DETECT INTERFERENCE AGAINST RUTHENIUM OR AGAINST STREPTAVIDIN SOLID PHASE. THERE WAS THE POSSIBILITY OF AN ANTI-IDIOTYPE OR ANTI-DIGOXIN INTERFERENCE, HOWEVER, DUE TO INSUFFICIENT SAMPLE VOLUME, FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED SEEING A SPARK FROM THE DOOR AREA OF THE STERILIZER. NO INJURIES WERE REPORTED TO PATIENTS OR HOSPITAL STAFF.

    Description of Event or Problem · 1

    THE USER HAD A PATIENT SAMPLE RESULT IN THE CRITICAL RANGE FOR DIGOXIN AND THE PATIENT WAS SENT TO THE ER. AT THE HOSPITAL, TESTING WAS DONE ON A NEW SAMPLE USING A BECKMAN ANALYZER AND THE RESULTS WERE NORMAL. THE INITIAL RESULT FROM THE E2010 WAS >5.0 NG/ML, REPEAT RESULT ON (B)(6) 2010 WAS >5.0 NG/ML AND WITH A 1:2 DILUTION WAS 8.21 NG/ML. ON (B)(6) 2010, THE PATIENT WAS SENT TO THE ER AND SAMPLE DRAWN THERE RESULTED AS 0.86 NG/ML ON THE BECKMAN DXC 600I. THAT SAMPLE WAS REPEATED FOR CONFIRMATION (B)(6) 2010 ON THE DXC 600 ANALYZER AND RESULTED 0.92 NG/ML. A SEPARATE SAMPLE DRAWN AT THE SAME TIME AS THE INITIAL WAS TESTED ON (B)(6) 2010 ON THE DXC 600 ANALYZER WITH A RESULT OF 1.83 NG/ML. THAT SAME SAMPLE WAS TESTED ON THE BECKMAN DXC 600I WITH A RESULT OF 1.65 NG/ML. THE INITIAL SAMPLE WAS REPEATED ON (B)(6) 2010 ON THE E170 ANALYZER AT A REFERENCE LAB WITH A RESULT OF >5.0NG/ML, REPEATED WITH A 1:2 DILUTION RESULTED AS 8.47 NG/ML. THE INITIAL SAMPLE WAS SENT TO ANOTHER HOSPITAL FOR TESTING ON (B)(6) 2010 WITH RESULTS OF 1.5, 1.4 AND 1.4 NG/ML. NO TREATMENT WAS GIVEN BASED ON THE RESULTS GENERATED BY THE E2010. THE PATIENT WAS CONTACTED BY THE ON-CALL PHYSICIAN WHO DID NOT KNOW OR EXAMINE THE PATIENT. HE RECOMMENDED THAT PATIENT GO TO ER. AT THE HOSPITAL, A SAMPLE WAS DRAWN FOR DIGOXIN, GLUCOSE, BUN AND CREATININE. ALL RESULTS WERE WITHIN NORMAL RANGES AND PATIENT WAS NOT ADMITTED. THE USER DID NOT WANT A SERVICE VISIT AND STATED SHE BELIEVES THE ISSUE IS PATIENT SAMPLE SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER KXT ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR DIGOXIN