BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 2971287 · Received November 16, 2007

    Report

    Report Number
    3004209178-2007-04736
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 7, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IS IT 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 STATED HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THE BLOOD GLUCOSE READING WAS 530 MG/DL. THE CUSTOMER STATED HE CHANGED THE INFUSION SET THREE DAYS PRIOR TO THE HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PROGRAMMING WAS CORRECT. THE CUSTOMER DID NOT HAVE SUPPLIES WITH HIM TO PERFORM FURTHER TESTING ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization