BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPRO2 RECORDER

    MDR report key: 4170088 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37776
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS UNABLE TO CHARGE DUE TO A BROKEN COW CATCHER AND DAMAGE TO ALL CONTACT PINS. THE FUNCTIONAL TESTS COULD NOT BE PERFORMED DUE TO THE CHARGE ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNRESPONSIVE AND THAT IT GAVE OFF A RED LIGHT. IT WAS REPORTED THAT THE GOLD PRONGS WERE AWKWARDLY POSITIONED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648916 IPRO2 RECORDER CGM MDS MEDTRONIC MINIMED MMT-7741

    Patients

    Seq Age Sex Outcome Treatment
    1