BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAB PRDGM INS BL EN US RC

    MDR report key: 1211711 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01839
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THAT SHE WAS TAKEN BY PARAMEDICS TO THE HOSPITAL TWICE DUE TO HYPOGLYCEMIA. DURING THE FIRST EVENT, THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS 19 MG/DL. DURING THE SECOND EVENT, THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS 27 MG/DL. THE CUSTOMER'S DOCTOR STATED THAT THE PROGRAMMING ON THE INSULIN PUMP WAS NOT RIGHT, SO HE LOWERED HER BASAL RATES FOLLOWING THE EVENTS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER IS PRACTICING THE PROPER PRIMING TECHNIQUE. THE DISPLACEMENT TEST PASSED. IT WAS FOUND THAT THE CUSTOMER MANIPULATES THE RESERVOIR DURING USE OF THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO ALWAYS BE DISCONNECTED FROM THE INSULIN PUMP WHEN HANDLING THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization