BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03804

    MDR report key: 4915425 · Received July 15, 2015

    Report

    Report Number
    1823260-2015-03804
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    April 23, 2015
    Report Date
    July 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

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, A GENERAL REAGENT ISSUE IS NOT LIKELY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS BEGINNING IN (B)(6) 2015. BASED ON THE DATA PROVIDED, 2 PATIENT SAMPLES TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG + B) WERE ERRONEOUS. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 HAS BEEN CAPTURED ON MEDWATCH WITH PATIENT IDENTIFIER (B)(6). PATIENT 2 INITIAL HCG + B RESULT WAS 144.3 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 86000 MIU/ML. THE REPEAT RESULT WAS CONSIDERED TO BE CORRECT. NO ADVERSE EVENT OCCURRED. THE HCG + B REAGENT LOT WAS 183183. THE EXPIRATION DATE WAS NOT PROVIDED. ON (B)(6) 2015, DURING A SERVICE VISIT, MAINTENANCE AND CLEANING WAS PERFORMED ON THE ANALYZER. THE PINCH TUBE WAS ALSO EXCHANGED.

    Patients

    Seq Age Sex Outcome Treatment
    1