BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAS PRDGM INSULIN SMOKE

    MDR report key: 1890139 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83240
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 600 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING PRIOR TO HIS ADMISSION. THE NURSE DECLINED TO TROUBLESHOOT THE INSULIN PUMP, AND SHE REQUESTED A REPRESENTATIVE TO COME TO THE HOSPITAL TO TEST THE DEVICE. THE NURSE ALSO REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION 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 11 YR Hospitalization