BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512NAL PRDGM INSULIN CL EN

    MDR report key: 1081817 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01273
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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 OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE AT WORK SHE HAD A HYPOGLYCEMIC REACTION AND PARAMEDICS HAD TO BE CALLED TO REVIVE HER. THE CUSTOMER STATED SHE FELT DIZZY AND LOST CONSCIOUSNESS PRIOR TO THE PARAMEDICS BEING CALLED. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE CUSTOMER HAD A BASAL PATTERN SET IN THE INSULIN PUMP THAT WAS HIGHER THAN HER STANDARD PATTERN. THE CUSTOMER DID NOT WANT TO CHECK THE HISTORY IN THE INSULIN PUMP TO SEE IF THIS BASAL PATTERN WAS RUNNING THE DAY OF THE EVENT. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER STATED SHE ONLY BOLUSES TO TREAT HER BLOOD GLUCOSE READING, AND DOES NOT BOLUS TO TREAT FOR FOOD. THE CUSTOMER STATED SHE KNOWS THIS IS NOT THE CORRECT BOLUSING METHOD, BUT SHE INSISTS ON CONTINUING TO BOLUS IN THIS MANNER BECAUSE IT IS THE WAY SHE HAS ALWAYS DONE IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention