BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1103184 · Received August 8, 2008

    Report

    Report Number
    2032227-2008-01366
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 386 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER STATED THAT WHILE ATTEMPTING TO PROGRAM THE INSULIN PUMP, SHE INADVERTENTLY TURNED ON THE BLOCK FEATURE. THE CUSTOMER STATED THAT SHE DID NOT KNOW HOW TO TURN THE BLOCK FEATURE OFF, SO FOR TWO DAYS PRIOR TO THE EVENT, SHE DID NOT BOLUS, LEADING TO THE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ASSISTED WITH TURNING THE BLOCK FEATURE OFF. NOTHING FURTHER WAS REPORTED.

    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