BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722WWL PRDGM INSULIN CL EN ML

    MDR report key: 1942377 · Received December 23, 2010

    Report

    Report Number
    3004209178-2010-83654
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE DEVICE FAILED THE TEST. IT WAS STATED THAT EVERY TIME THE LEAD SCREW GETS HALF WAY THROUGH THE RESERVOIR COMPARTMENT, THE INSULIN PUMP ALARMS MOTOR ERROR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722WWL PRDGM INSULIN CL EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1