BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3022117 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-92090
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S INSULIN PUMP IS NOT FUNCTIONING PROPERLY. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 25MG/DL THEN 52MG/DL THE NIGHT BEFORE. THE CUSTOMER ATE CHOCOLATE AND HIS BLOOD GLUCOSE WENT UP TO 110MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE CALLER STATED THAT THE DEVICE ALARMED. IT WAS ALSO MENTIONED THAT THE DRIVE SUPPORT CAP WAS LOOSE AND POPPED OUT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123476 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR