BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1942223 · Received December 22, 2010

    Report

    Report Number
    2032227-2010-83516
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    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 THAT SHE FELT THE INSULIN PUMP WAS OVER DELIVERING INSULIN. THE CUSTOMER STATED THAT SHE HAS TO MAINTAIN HER BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL TO AVOID SUDDENLY DROPPING INTO THE 40 MG/DL RANGE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER STATED THAT SHE HAS BEEN MAKING ADJUSTMENTS TO THE INSULIN PUMP SETTINGS WITHOUT FIRST DISCUSSING THEM WITH HER DOCTOR. ADVISED THAT SHE SHOULD FIRST DISCUSS WITH HER DOCTOR PRIOR TO MAKING ANY CHANGES TO THE INSULIN PUMP SETTINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR