BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972042 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05062
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    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 BATTERY ON THE INSULIN PUMP IS NOT LASTING MORE THAN 12 HOURS. CUSTOMER STATED THAT SHE CHANGED THE BATTERY MULTIPLE TIMES AND THE SCREEN DISPLAY IS BLANK. DURING TROUBLESHOOT; IT WAS STATED THAT THERE IS CORROSION INSIDE THE BATTERY CAP AND THE CONTACTS ON THE BATTERY CAP ARE DAMAGED. IT WAS ALSO STATED THAT THE INSULIN PUMP IS ALARMING FOR HIGH BLOOD GLUCOSE AND SHE IS NORMALLY 5 MMOL/L. CURRENT BLOOD GLUCOSE IS 11 MMOL/L. THE BATTERY CAP IS BEING REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448452 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAB

    Patients

    Seq Age Sex Outcome Treatment
    1