BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1000449 · Received February 21, 2008

    Report

    Report Number
    2032227-2008-00374
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE HAS BEEN BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER HAD TO BE TREATED BY PARAMEDICS WHILE AT SCHOOL DUE TO HYPOGLYCEMIA. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE CUSTOMER HAD DELIVERED A 25 UNIT BOLUS AT LUNCH. THE CUSTOMER STATED THAT HE HAD PROGRAMMED A 12.5 UNIT BOLUS FOR LUNCH. THE CUSTOMER'S MOTHER LOWERED THE MAXIMUM BOLUS DELIVERY ON THE INSULIN PUMP SO THAT IT COULD NOT DELIVER MORE THAN 15 UNITS AFTER THE EVENT. DURING THE PHONE CALL THE MOTHER PROGRAMMED A BOLUS WHILE THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND NO ANOMALIES WERE FOUND WITH THE BOLUS DELIVERY. NOTHING FURTHER WAS REPORTED.

    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 Required Intervention