BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1023248 · Received March 31, 2008

    Report

    Report Number
    2032227-2008-00577
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    THE CUSTOMER STATED SHE WAS HOSPITALIZED WITH HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING READ "HI". THE CUSTOMER STATED THAT SHE DID NOT CHANGE HER INFUSION SET AFTER EXPERIENCING THE HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization