BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4162022 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36081
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 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 HAD TROUBLE WITH THE RESERVOIR. CUSTOMER STATED THAT THE RESERVOIR KEPT TWISTING OUT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 563 MG/DL. CUSTOMER TREATED WITH THE PUMP. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER CHECKED THE RESERVOIR COMPARTMENT AND FOUND THAT THERE WAS A PIECE MISSING AND THAT WAS WHY THE RESERVOIR WAS NOT STAYING IN. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER DECLINED TO HAVE PUMP SENT SINCE SHE DOES NOT HAVE INSURANCE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644591 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 49 YR