BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142235 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33653
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE LCD BOARD. MOISTURE DAMAGE WAS FOUND ON THE MOTOR ALSO. THE DEVICE WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND A MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE TO IT, INCLUDING CRACKS WHICH OCCURRED WHEN THE DEVICE WAS HIT AGAINST A CABINET. THE CALLER ALSO NOTED THAT THERE WAS DAMAGE TO THE RESERVOIR AREA. THE BLOOD GLUCOSE READING WAS 174 MG/DL. A BLANK DISPLAY WAS ALSO REPORTED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621898 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR