BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-06132

    MDR report key: 5330397 · Received December 28, 2015

    Report

    Report Number
    1823260-2015-06132
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    December 15, 2015
    Report Date
    February 11, 2016
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FOR PATIENT SAMPLES AND QC. DATA WAS PROVIDED FOR ONE SAMPLE AS A RESULT OF 800, THEN 85, THEN 416. NO UNIT OF MEASURE WAS PROVIDED. THE CUSTOMER NOTICED A "NOISY SOUND" WHEN THE ANALYZER PIPETTED A SAMPLE. THE CUSTOMER CLEANED THE PROBE ARM THEN RAN QC WHICH WAS IN RANGE AND REPEATED THE PATIENT SAMPLE WITH A RESULT OF 3.6. THE CUSTOMER TESTED THE SAMPLE USING A RAPID TEST (CARD) AND THE RESULT WAS NEGATIVE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 183183 WITH AN EXPIRATION DATE OF 06/30/2016.

    Patients

    Seq Age Sex Outcome Treatment
    1