BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 1900066 · Received November 8, 2010

    Report

    Report Number
    3004209178-2010-83278
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN PROPERLY, AND THE CUSTOMER'S DOCTOR WANTED IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1