BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAS PRDGM INS SK EN RC

    MDR report key: 2954053 · Received November 28, 2007

    Report

    Report Number
    3004209178-2007-04718
    Event Type
    Injury
    Date Received
    November 28, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 14, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 STATED THAT THE CUSTOMER WAS TREATED BY THE PARAMEDICS FOR LOW BLOOD GLUCOSE. THE REPORTED BLOOD GLUCOSE READING DURING THE PHONE CALL WAS 80 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS CONNECTED TO THE INFUSION SET WHILE PERFORMING THE MANUAL PRIME AND RECEIVED 120 UNITS OF INSULIN. TROUBLESHOOTING REVEALED THAT THE CUSTOMER IS A NEW INSULIN PUMP USER AND THIS WAS THE FIRST TIME HE CHANGED THE INFUSION SET ON HIS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAS PRDGM INS SK EN RC INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention