BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2. CL EN PR

    MDR report key: 1890161 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83242
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 32 MG/DL. THE CUSTOMER WAS TREATED WITH GLUCAGON GEL AND GLUCAGON SHOT. THE CUSTOMER STATED THAT HE WAS NOT SURE IF THE FOOD INTAKE MAY HAVE CAUSED HIS LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT HIS INFUSION SET WAS CHANGED TWO DAYS AGO AND BEFORE THE CALL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE CORRECT. REVIEWED THE BASAL, BOLUS HISTORY, AND DAILY TOTALS AND FOUND EVERYTHING ADDED UP PROPERLY. THE CUSTOMER ALSO STATED THAT HIS ACTIVITY LEVEL HAS CHANGED DUE TO THE WORK HE DOES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization