BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1133355 · Received August 22, 2008

    Report

    Report Number
    2032227-2008-01439
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 600 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A BLANK SCREEN. THE CUSTOMER STATED CHANGING THREE INFUSION SETS PRIOR TO HER HOSPITALIZATION AND TOOK MANUAL INJECTIONS AS WELL AND THE BLOOD GLUCOSE DID NOT LOWER. ADVISED CUSTOMER THAT THE INSULIN MAY HAVE BEEN DENATURED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization