BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03937

    MDR report key: 4996422 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03937
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 21, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED. IT WAS NOTED THE SYSTEM WAS OVERDUE FOR MAINTENANCE AND CALIBRATION. THIS MAY HAVE CONTRIBUTED TO THE ISSUE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FOR TWO PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 0.412 MIU/ML. THE REPEAT RESULTS WERE 0.114 MIU/ML AND <0.100 MIU/ML WITH A DATA FLAG. ALL RESULTS WERE OBTAINED FROM A SAMPLE CUP. NO RESULTS WERE 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. IT WAS NOTED THE CUSTOMER DID NOT FOLLOW THE TUBE MANUFACTURER'S RECOMMENDATION FOR SAMPLE CLOTTING TIME.

    Patients

    Seq Age Sex Outcome Treatment
    1