BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04329

    MDR report key: 5147624 · Received October 14, 2015

    Report

    Report Number
    1823260-2015-04329
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 27, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE FIELD SERVICE REPRESENTATIVE PERFORMED PREVENTIVE MAINTENANCE AND EXCHANGED THE MEASURING CELL. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED. A GENERAL INSTRUMENT ISSUE WAS POSSIBLE AS THE QC GAVE A BAD RESULT AFTER THE ISSUE AND GOOD RESULTS WERE RECEIVED FROM THE SAME REAGENT PACK AFTER RECALIBRATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FOR THREE PATIENT SAMPLES PATIENT 1: INITIAL RESULT WAS 827.8 MUI/ML. THE REPEAT RESULT WAS 42.32 MUI/ML. AFTER CALIBRATION, THE RESULTS WERE 0.864 MUI/ML AND <0.100 MUI/ML. THE RESULT OF <0.100 MUI/ML WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2: (FEMALE, (B)(6) YEAR OLD, BIRTHDATE (B)(6) 1997) INITIAL RESULT WAS 244.5 MUI/ML. AFTER CALIBRATION, THE RESULT WAS <0.100 MUI/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 3: (FEMALE, (B)(6) YEAR OLD, BIRTHDATE (B)(6) 1982) INITIAL RESULT WAS 251.2 MUI/ML. AFTER CALIBRATION, THE RESULT WAS 1.17 MUI/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT. A RAPID TEST WAS ALSO PERFORMED AND THE RESULTS WERE NEGATIVE. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 185430. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS AND WAS ALSO NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDATION FOR SAMPLE CLOTTING TIME.

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR