BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4031737 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-97187
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD NOT BEEN USING THE INSULIN PUMP FOR NINE MONTHS. CUSTOMER WAS READY TO START USING IT AGAIN AND STATED THAT WHEN INSERTING THE BATTERY, THE DISPLAY IS BLANK, DEVICE IS NOT RESPONDING. CUSTOMER HAS OWNED THE INSULIN PUMP FOR THREE YEARS. CUSTOMER STATED THAT THE BATTERY CAP IS DAMAGED. NO OTHER DAMAGE TO THE INSULIN PUMP WAS REPORTED. THE BATTERY CAP WILL BE REPLACED. BLOOD GLUCOSE IS 6.7 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510133 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1