BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAB PRDGM INS V2.1 BL EN

    MDR report key: 917646 · Received September 24, 2007

    Report

    Report Number
    2032227-2007-01778
    Event Type
    Injury
    Date Received
    September 24, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 7, 2007
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS THE DEVICE HAS NOT YET BEEN EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER NFO WILL FOLLOW INFO ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THE BLOOD GLUCOSE READING WAS 319 MG/DL. IT WAS STATED THAT PRIOR TO THE HOSPITALIZATION, THE CUSTOMER WOKE UP WITH HIGH BLOOD GLUCOSE AND WAS VOMITING. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. THE PROGRAMMING WAS CORRECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization