BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3984470 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90280
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A SEVERELY SCRATCHED DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CUSTOMER THAT THE INSULIN PUMP HAS COSMETIC DAMAGE AND HAS A CLOUDY RESERVOIR WINDOW. CUSTOMER MOST RECENT BLOOD GLUCOE IS 13.8 MMOL/DL. CUSTOMER STATES THE RESERVOIR WINDOW HAS SOME SCRATCHES, WHICH MAY HAVE BEEN CAUSED BY HIS CASE. ADVISED CUSTOMER TO DISCONTINUE THE USE OF THE PUMP AND REVERT TO HIS BACKUP PLAN PER HIS HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459438 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMH

    Patients

    Seq Age Sex Outcome Treatment
    1