BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03867

    MDR report key: 4943405 · Received July 27, 2015

    Report

    Report Number
    1823260-2015-03867
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 29, 2015
    Report Date
    August 21, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    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 436.3 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE GYNECOLOGIST QUESTIONED THE RESULT AS THE PATIENT WAS PREGNANT AND THE RESULT SHOULD HAVE BEEN HIGHER. THE LAB REPEATED TESTING ON THE SAME SAMPLE WITH A 1:100 DILUTION AND THE RESULT WAS 89910 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1