BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1902374 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83308
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    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 BEING IN THE HOSPITAL FOR HIGH BLOOD GLUCOSE OF 469 MG/DL. THE CUSTOMER STATED THAT HE WAS FIGHTING A COLD AT THE TIME OF THE ADMITTANCE. THE CUSTOMER ALSO STATED THAT HE HAD AN INFECTION AND WAS DEHYDRATED. THE CUSTOMER STATED THAT HE WAITS AT LEAST A WEEK TO CHANGE THE INFUSION SET AND RESERVOIR. ADVISED CUSTOMER TO CHANGE THE INFUSION SET AND RESERVOIR EVERY TWO TO THREE DAYS. THE CUSTOMER STATED THAT HE FILLS THE RESERVOIR STRAIGHT FROM HIS REFRIGERATOR. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization