BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523RNAS PRDGM INS V2.3 SK EN RC

    MDR report key: 1780967 · Received July 27, 2010

    Report

    Report Number
    2032227-2010-82040
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. 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, WITH BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL. THE CUSTOMER HAD NAUSEA, VOMITING AND KETONES. IT WAS ALSO STATED THAT THE CANNULA HAD BROKEN OFF AND STAYED UNDERNEATH HIS SKIN. THE NURSE WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL, AND WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523RNAS PRDGM INS V2.3 SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization