BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522WWS PRDGM INSULIN SK EN ML

    MDR report key: 1890162 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83244
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 HIGH BLOOD GLUCOSE OF 31 MMOL/L. IT WAS STATED THAT THE CUSTOMER HAD KETOACIDS IN THE BLOOD AND URINE. IT WAS STATED THAT THE CANNULA WAS BENT, AND THE CUSTOMER CHANGED THE INFUSION SET AFTER HER BLOOD GLUCOSE WAS VERY HIGH. TROUBLESHOOTING WAS DECLINED. NO FURTHER INFO 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