BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAB PRDGM INSULIN BL EN

    MDR report key: 1111036 · Received August 12, 2008

    Report

    Report Number
    2032227-2008-01377
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 30 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS UNCONSCIOUS AND UNRESPONSIVE WHEN THE PARAMEDICS ARRIVED. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER STATED THAT HE HAD PROGRAMMED A TEMPORARY BASAL RATE INCORRECTLY. THE CUSTOMER STATED THAT HE INTENDED TO PROGRAM A BASAL RATE OF 0.8 UNITS OF INSULIN, BUT HE ACCIDENTLY PROGRAMMED A BASAL RATE OF 8.0 UNITS INSTEAD. THE CUSTOMER STATED THAT THIS WAS THE CAUSE OF THE EVENT. THE CUSTOMER ALSO STATED THAT THE CONTACTS ON THE KEYPAD WERE EXPOSED, BUT THE BUTTONS WERE STILL RESPONDING NORMALLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAB PRDGM INSULIN BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention