BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4190430 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41115
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 THE INSULIN PUMP SCREEN WAS SCRATCHED AND DIFFICULT TO READ. THERE WAS ALSO CONDENSATION INSIDE THE SCREEN. CUSTOMER HAD TO DO A FREQUENT BATTERY CHANGES AND THE DEVICE REJECTED NEW BATTERIES. CUSTOMER HAS TO REWIND THE DEVICE TO COMPLETE RESTART. THE ACT BUTTON ON THE DEVICE WAS ALSO STUCK. THE DEVICE POSSIBLY CAUSED HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667540 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR