BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2250956 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82781
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING THE INSULIN PROPERLY. THE CUSTOMER STATED THAT THE INSULIN PUMP AT TIMES DELIVERS A BOLUS, AND THEN AFTERWARDS SHE NOTICES THAT THE INSULIN PUMP AUTOMATICALLY TRIES TO DELIVER THE SAME BOLUS AGAIN. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT RECORDING ALL HER BOLUSES. THE CUSTOMER STATED THAT TWO WEEKS AGO SHE TOOK A BOLUS, AND WHEN SHE REVIEWED THE BOLUS HISTORY, IT WAS NOT RECORDED. THE CUSTOMER ALSO STATED THAT THE BACKLIGHT WAS TURNING ON ITS OWN AND THE SCREEN WAS FLICKERING. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR