BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1060342 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00980
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS GOING TO BE TAKEN TO THE HOSPITAL DUE TO HYPERGLYCEMIA. THE CUSTOMER'S MOTHER STATED THE CUSTOMER HAD BEEN TREATING HERSELF WITH MANUAL INJECTIONS, BUT HER BLOOD GLUCOSE LEVELS REMAINED HIGH. THE REPORTED BLOOD GLUCOSE READING WAS 300 MG/DL. THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS NO LONGER COMFORTABLE USING THE INSULIN PUMP, SO A REPLACEMENT INSULIN PUMP WAS SENT TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization