BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UC EA INSULIN CH EN US

    MDR report key: 1202938 · Received October 15, 2008

    Report

    Report Number
    2032227-2008-01789
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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, 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'S NURSE REPORTED THAT THE CUSTOMER WAS FOUND UNCONSCIOUS AND COULD NOT BE REVIVED BY HIS FAMILY. THE CUSTOMER WAS THEN TAKEN BY PARAMEDICS TO THE HOSP DUE TO HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE LEAD SCREW TEST. THE CUSTOMER'S NURSE STATED THAT SHE WILL CONFIRM THAT THE INSULIN PUMP IS PROGRAMMED CORRECTLY. AT THE TIME OF THE PHONE CALL, THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UC EA INSULIN CH EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization