BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1870120 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82915
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 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 STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OF 700 MG/DL. THE CUSTOMER STATES, SHE HAD CHANGED THE INFUSION SET TWICE BEFORE GOING TO THE HOSPITAL AND WAS ADMITTED BECAUSE OF SEVERE CHEST PAIN, NAUSEA, AND VOMITING. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME TEST BUT NO HIGH PRESSURE TEST WAS PERFORMED BECAUSE THE CUSTOMER DID NOT HAVE A TUBING CLAMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization