BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAS PRDGM INSULIN SMOKE

    MDR report key: 1882601 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83192
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 12, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE MOTHER STATED THAT HER SON'S BLOOD GLUCOSE READING WAS BETWEEN 300 AND 400MG/DL. THE CUSTOMER STATED THAT SOME OF THE SETTINGS ON THE DEVICE WERE CHANGED BY THE HOSPITAL STAFF. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED THE HIGH PRESSURE TWICE AND THE DEVICE FAILED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAS PRDGM INSULIN SMOKE INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization