BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1941926 · Received December 23, 2010

    Report

    Report Number
    3004209178-2010-83660
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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 FOR HIGH BLOOD GLUCOSE OF 23.8MMOL/L. IT WAS STATED THAT THE CUSTOMER WENT TO THE HOSPITAL BECAUSE SHE WAS OUT OF INSULIN AND IT WAS FASTER TO GO THE HOSPITAL THAN TO BE TREATED AT HOME. IT WAS ALSO STATED THAT THE CUSTOMER NOTICED A CRACK ALONG THE TUBING OF HER INFUSION SET, WHICH CAUSED HER HIGH GLUCOSE LEVEL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization