BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4131921 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31296
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. INSULIN PUMP WAS UNABLE TO VERIFY BUTTON ERROR ALARM DUE TO BLANK DISPLAY. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND SCRATCHED CASE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER WAS PUSHED IN THE POOL WITH THEIR INSULIN DEVICE ATTACHED TO THEM. THE CUSTOMER HAS A BLOOD GLUCOSE LEVEL WAS NOT RECORDED. THE CUSTOMER STATES THAT THERE IS FLUID/MOISTURE IN THE DEVICE. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611923 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR