BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03847

    MDR report key: 4936076 · Received July 23, 2015

    Report

    Report Number
    1823260-2015-03847
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 28, 2015
    Report Date
    August 17, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE ERRONEOUS RESULTS OCCURRED WITHIN A 4 HOUR TIMEFRAME. IT IS LIKELY THAT THE ROOT CAUSE CAN BE ATTRIBUTED TO AN ISSUE THAT OCCURRED WITHIN THIS TIMEFRAME. THE POSSIBLE ROOT CAUSE MAY BE RELATED TO PRE-ANALYTICS, BUT THIS COULD NOT BE CONFIRMED AS ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RAN QUALITY CONTROLS (QC) ON (B)(6) 2015 ON THE E170 ANALYZER AND THE RESULTS WERE NOT ACCEPTABLE. THE INSTRUMENT WAS NOT USED ANYMORE. THE CUSTOMER DECIDED TO REPEAT PATIENT SAMPLES TESTED BEFORE THE QC WAS RUN TO CHECK FOR DISCREPANCIES. THE CUSTOMER IDENTIFIED ERRONEOUS RESULTS FOR 7 PATIENT SAMPLES TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG + B). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON A DIFFERENT E170 ANALYZER FROM THE SAME PRIMARY TUBE. THE RESULTS OF THE REPEAT TESTS WERE ALSO REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL HCG + B RESULT WAS <0.100 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 0.405 MUI/ML. PATIENT 2 (FEMALE) INITIAL HCG + B RESULT WAS <0.100 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 0.355 MUI/ML. PATIENT 3 (FEMALE) INITIAL HCG + B RESULT WAS 4.01 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 8.05 MUI/ML. PATIENT 4 (FEMALE) INITIAL HCG + B RESULT WAS <0.100 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 33.12 MUI/ML. PATIENT 5 (FEMALE) INITIAL HCG + B RESULT WAS 0.267 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 10.43 MUI/ML. PATIENT 6 (FEMALE) INITIAL HCG + B RESULT WAS <0.100 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 2.85 MUI/ML. PATIENT 7 (FEMALE) INITIAL HCG + B RESULT WAS <0.100 MUI/ML. THE REPEAT RESULT ON (B)(6) 2015 WAS 1.06 MUI/ML. NO ADVERSE EVENTS WERE REPORTED. THE HCG + B REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS NOT PROVIDED. QC RESULTS PRIOR TO THE EVENT WERE ACCEPTABLE. BETWEEN (B)(6) 2015 CORRECTIVE MAINTENANCE WAS PERFORMED ON THE INSTRUMENT WHERE ADJUSTMENTS AND EXCHANGES WERE MADE. AN ANALYZER PERFORMANCE CHECK WAS PERFORMED AT THIS TIME AND THE RESULTS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE ON (B)(4) 2015 AND DID NOT IDENTIFY ANYTHING THAT COULD BE THE ROOT CAUSE OF THIS ISSUE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. IT WAS NOTED THAT THE CUSTOMER HAS HAD PREVIOUS ISSUES WITH PRE-ANALYTICS.

    Patients

    Seq Age Sex Outcome Treatment
    1