BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02175

    MDR report key: 6910201 · Received October 3, 2017

    Report

    Report Number
    1823260-2017-02175
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 3, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN(B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HBCB) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE SAMPLE INITIALLY RESULTED AS < 1.0 IU/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS REFERRED TO A GYNECOLOGIST FOR FURTHER INVESTIGATION BASED ON THE RESULT. THE SAMPLE WAS REPEATED BASED ON THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED ON A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER AND THE RESULT WAS 3899 IU/L ON (B)(6) 2017. AN AMENDED RESULT REPORT WAS ISSUED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HCGB REAGENT LOT NUMBER WAS 240444. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. LIQUID FLOW CLEANING WAS PERFORMED ON THE ANALYZER ON (B)(6) 2017 AND PINCH TUBING WAS ALSO CHANGED ON THIS DATE. THE FIELD SERVICE ENGINEER CHECKED THE FLUID FLOW OF THE PROBES; THESE WERE VERY GOOD. HE RAN A SYSTEM VOLUME CHECK AND THIS PASSED OK. HE CHECKED THE CONDITION OF THE PINCH TUBES AND THESE WERE OK. HE PERFORMED A SIPPER CHECK AND NOTICED THAT AS THE SIPPER PROBE LIFTED FROM THE CUP IN THE SIPPING POSITION, THE CUP WAS LIFTED. HE ADJUSTED THE SIPPER PROBE. HE ADJUSTED THE SAMPLE PROBE. HE CHECKED AND ADJUSTED THE MIXER ASSEMBLY. HE RAN A HIGH VOLTAGE SIGNAL CHECK AND ADJUSTED THIS. HE RAN PERFORMANCE TESTING AND THIS PASSED. HE RAN A BLANK CELL CALIBRATION AND THIS PASSED OK. HE RAN CALIBRATION AND QUALITY CONTROLS; THESE WERE ALL OK. THE EVENT WAS A SINGLE OCCURRENCE AND THE CUSTOMER REPORTED NO OTHER DISCREPANT RESULTS. THE CUSTOMER CONFIRMED THAT ALL MAINTENANCE IS UP TO DATE ON THE INSTRUMENT. THE MEASURING CELL HAD NOT BEEN CHANGED ON THE INSTRUMENT SINCE IT WAS FIRST INSTALLED IN (B)(6) 2016.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR