BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03761

    MDR report key: 4894817 · Received July 7, 2015

    Report

    Report Number
    1823260-2015-03761
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 23, 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. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 18.05 MUI/ML. THE REPEAT RESULTS WERE 10000 MUI/ML WITH A DATA FLAG, 17946 MUI/ML WITH A 1:100 DILUTION AND 16737 MUI/ML WITH A 1:100 DILUTION. THE RESULT OF 16737 MUI/ML WAS REPORTED OUTSIDE THE LAB. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 175253. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR