BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522WWS PRDGM INSULIN SK EN ML

    MDR report key: 1902382 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83309
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED. IT WAS STATED THAT THE CUSTOMER HAD DIFFICULTIES WITH THE RESERVOIRS AND THE GENERIC INFUSION SETS. THE CUSTOMER'S BLOOD GLUCOSE HAS BEEN UNSTABLE, AND THE GLUCOSE LEVEL WENT FROM HIGH TO VERY LOW. IT WAS STATED THAT THE CUSTOMER HAD HEAD TRAUMA AND WAS UNCONSCIOUSNESS. IT WAS STATED THAT THE DOCTOR AND THE NURSE WERE CONVINCED THAT THIS INCIDENT WAS CAUSED BY USING THE GENERIC INFUSION SETS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWS PRDGM INSULIN SK EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization