BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAB PRDGM INS BL EN US LN

    MDR report key: 1033884 · Received April 24, 2008

    Report

    Report Number
    2032227-2008-00709
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS. ALSO FOUND SEVERAL NO DELIVERY ALARMS IN THE ALARM HISTORY, ALL FROM THE DAY OF THE HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization