BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03563

    MDR report key: 4809200 · Received June 1, 2015

    Report

    Report Number
    1823260-2015-03563
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 5, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). SERIAL NUMBERS (B)(4) WERE PROVIDED. CLARIFICATION OF WHICH SERIAL NUMBER WAS CORRECT WAS REQUESTED.

    Additional Manufacturer Narrative · 1

    CLARIFICATION WAS RECEIVED THAT THE CORRECT SERIAL NUMBER OF THE ANALYZER WAS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FOR SEVERAL PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT ON ANOTHER MODULE WAS 0.100 IU/L WITH A DATA FLAG. LATER IN THE EVENING, THE SAMPLE WAS REPEATED ON THE SUSPECT MODULE AND THE RESULTS WERE 1300 IU/L AND 236.1 IU/L. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. THE CUSTOMER FOUND ONE PINCH TUBE WAS CRUMBLED AT THE PINCH VALVE AND CHANGED THE PINCH TUBING.

    Patients

    Seq Age Sex Outcome Treatment
    1