BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1063319 · Received June 18, 2008

    Report

    Report Number
    2032227-2008-01015
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    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. 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

    IT WAS REPORTED THAT THE CUSTOMER WENT TO HER DOCTOR'S OFFICE AND SHE LOOKED PALE. HER DOCTOR TESTED HER BLOOD GLUCOSE AND FOUND THAT HER GLUCOSE LEVEL WAS OVER 500MG/DL. ALSO, THE CUSTOMER HAD KEYTONES. THE CUSTOMER WAS TRANSPORTED BY WHEELCHAIR TO THE HOSP AND TREATED FOR SEVERAL HRS. TROUBLESHOOTING WAS PERFORMED. THE FIXED PRIME AND HIGH-PRESSURE TESTS PASSED. ADVISED CUSTOMER TO CHANGE HER INFUSION SET WHEN SHE GETS HOME AND MONITOR HER GLUCOSE LEVELS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization