BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1841486 · Received September 16, 2010

    Report

    Report Number
    3004209178-2010-82808
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS GETTING NO DELIVERY ALARMS ON AND OFF FOR THE PAST TWO WEEKS. THE CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 18.5 MMOL/L. THE CUSTOMER TREATED HIS GLUCOSE LEVEL WITH 3.0 UNITS OF INSULIN. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE PISTON KEPT GOING AND EMPTIED THE ENTIRE RESERVOIR. ALSO, THE DEVICE ALARMED NO DELIVERY. THE RESERVOIR WAS CHANGED AND THE PISTON KEPT GOING, EMPTIED THE RESERVOIR, AND THE DEVICE ALARMED FOR A SECOND TIME. RAN A DISPLACEMENT TEST AND THE DEVICE FAILED THE TEST. NO FURTHER INFO WAS PROVIDED.

    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 14 YR