BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01845

    MDR report key: 6827826 · Received August 29, 2017

    Report

    Report Number
    1823260-2017-01845
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 9, 2017
    Report Date
    September 27, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. IT WAS DETERMINED SOME MAINTENANCE ACTIONS WERE OVERDUE AND THE LABORATORY WATER QUALITY WAS NOT BEING MONITORED. THESE WERE POSSIBLE CAUSES FOR THE ISSUE. THE CALIBRATION AND QC DATA PROVIDED WAS ACCEPTABLE AND DID NOT INDICATE ANY ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR TWO PATIENT SAMPLES. PATIENT 1 RESULTS WERE 3.51 MIU/ML, 97.77 MIU/ML, 6.60 MIU/ML, AND 3.28 MIU/ML. PATIENT 2 RESULTS WERE 75.47 MIU/ML, 0.758 MIU/ML, AND 5.25 MIU/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. CARRYOVER FROM A PREVIOUSLY TESTED HIGH SAMPLE WAS SUSPECTED. ANALYZER PERFORMANCE TESTING WAS ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1