BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3233294 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-95801
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED SHE IN THE HOSPITAL FOR KNEE SURGERY AND THE INSULIN PUMP STOPPED FUNCTIONING. THE CALLER STATED THAT SHE CHANGED THE SITE AND RECEIVED A NO DELIVERY ALARM. ASSISTED THE CALLER TO INSERT A NEW INFUSION SET AND TO PRIME. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WENT UP TO 367MG/D, AND PRIOR IT WAS 327MG/DL. THE CUSTOMER WAS UNSURE IF HER BLOOD GLUCOSE IS HIGH BECAUSE OF THE ALARM OR BECAUSE SHE IS IN PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333172 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization