BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03666

    MDR report key: 4851494 · Received June 17, 2015

    Report

    Report Number
    1823260-2015-03666
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 6, 2015
    Report Date
    July 13, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER DETERMINED THAT THE CUSTOMER WAS USING 13MM DIAMETER TUBES, WHICH ARE WITHIN SPECIFICATIONS. INVESTIGATIONS COULD NOT DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE PROVIDED INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS- SUBUNIT (HCGB). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED IN A TUBE WITHOUT GEL AND RESULTED AS 0.16 UI/L. THE GEL TUBE OF THE SAME SAMPLE WAS REPEATED AND RESULTED AS 4052 UI/L. THE ORIGINAL TUBE WAS THEN REPEATED ON (B)(6) 2015, RESULTING AS 4057 UI/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCGB REAGENT LOT NUMBER WAS 183183. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND RAN PERFORMANCE TESTING. PERFORMANCE TESTING AND CHECKS WERE OK. IT WAS DETERMINED THAT THE SAMPLE WAS MEASURED IN A 11MM DIAMETER TUBE, WHICH IS OUTSIDE OF THE SPECIFICATIONS FOR THE ANALYZER.

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR