BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1911772 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-83424
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED IN TWO DIFFERENT OCCASIONS FOR DIABETES KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DOCTOR DETERMINED THE INSULIN PUMP WAS NOT FUNCTIONING. FOUND THE CUSTOMER HAD BENT CANNULAS AND NO DELIVERY ALARMS. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET AND RESERVOIR MULTIPLE TIMES AND THE DEVICE CONTINUED ALARMING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization