BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03580

    MDR report key: 4817577 · Received June 4, 2015

    Report

    Report Number
    1823260-2015-03580
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 15, 2015
    Report Date
    July 7, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE REPLACED AND TIGHTENED THE BELTS, INSTALLED A PRINTER, CHECKED AND CORRECTED ALL ADJUSTMENTS AND CLEANED OUT THE WASTE MECHANISM. HE RAN PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE DATA, NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A GENERAL REAGENT ISSUE WAS NOT SUSPECTED.

    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 FOUR PATIENT SAMPLES SINCE 05/04/2015. OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, ONLY THE RESULTS FOR ONE WERE DISCREPANT. THE INITIAL RESULT WAS 0.1 IU/L. THE REPEAT RESULT WERE 0.2 IU/L, >10,000 IU/L, AND 22964 IU/L WITH A DILUTION. THE ERRONEOUS RESULT WAS REPORTED FROM THE LABORATORY. THE DOCTOR QUERIED THE RESULT SO IT WAS NOT ACTED UPON. THERE WAS NO ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 183183 WITH AN EXPIRATION DATE OF 05/30/2016. THE FIELD SERVICE REPRESENTATIVE PERFORMED SERVICE AND RAN PERFORMANCE TESTING.

    Patients

    Seq Age Sex Outcome Treatment
    1