BEUDAMED
    FDA Adverse Event Summary report: N

    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

    MDR report key: 6993473 · Received November 1, 2017

    Report

    Report Number
    MW5073063
    Date Received
    November 1, 2017
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2017
    Manufacturer
    FUTURE DIAGNOSTICS B.V.
    Product Code
    CEW
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REGARDING THE FOLLOWING ASSAY: FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT 510(K): K000471. PACKAGE INSERT FOR ASSAY DOES NOT DEFINE THAT CALIBRATION IS GOOD FOR 24 HOURS OR, IF THE INSTRUMENT IS MOVED OR POWERED DOWN, RECALIBRATION MUST TAKE PLACE. THESE FACTS WERE ONLY OBTAINED UPON QUESTIONING OF MANUFACTURER ABOUT THE LACK OF INFORMATION REGARDING CALIBRATION FREQUENCY AND STABILITY. LABORATORY DEVELOPED ITS OWN PROCEDURE TO CALIBRATE OFF-SITE AND MOVE EQUIPMENT TO THE PATIENT (SOME DISTANCE AND FLOORS AWAY). RESEARCHING WHETHER THIS WOULD BE PERMISSIBLE, IDENTIFIED THAT NO GUIDANCE WAS AVAILABLE FROM THE MANUFACTURER, PROMPTING EMAIL CONTACT AND RECEIPT OF THE INFORMATION ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774833 FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW FUTURE DIAGNOSTICS B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1