BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UB EA INSULIN BL EN US

    MDR report key: 1052829 · Received May 27, 2008

    Report

    Report Number
    2032227-2008-00890
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED FOR THE EVENT. IT WAS STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS AT HER HOME PRIOR TO BEING HOSPITALIZED. THE CUSTOMER HAS ALSO BEEN UNDER A LOT OF STRESS DUE TO HER JOB. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE LEADSCREW TEST. IT WAS ALSO STATED THAT THE BUTTONS WERE NOT FUNCTIONING PROPERLY AND THE CUSTOMER WAS HAVING A DIFFICULT TIME PROGRAMMING HER BASAL RATES. THE INSULIN PUMP WAS OUT OF WARRANTY AND THE CUSTOMER WAS UNABLE TO UPGRADE AT THIS TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UB EA INSULIN BL EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization