BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UB EA INSULIN BL EN US

    MDR report key: 1031175 · Received April 17, 2008

    Report

    Report Number
    2032227-2008-00661
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING REVEALED THAT THE INSULIN PUMP HAD GIVEN SEVERAL ALARMS IN THE ALARM HISTORY. THE NURSE DID NOT HAVE TIME TO TROUBLESHOOT FURTHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization