BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LWWL PRDGM INS CL EN LN

    MDR report key: 1951855 · Received December 28, 2010

    Report

    Report Number
    2032227-2010-83584
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 12, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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. THE BLOOD GLUCOSE READING WAS 48MMOL/L. IT WAS STATED THAT THE DOCTOR RECOMMENDED CHANGING THE BASALS. THE CUSTOMER CALLED AND REQUESTED ASSISTANCE WITH CHANGING SETTINGS. IT WAS STATED THAT THE BASAL RATES WERE DELETED IN THE MORNING. THEN, THE BASALS WERE REPROGRAMMED, BUT LATER, THE BASALS WERE DELETED AGAIN. THE BOLUS HISTORY DID NOT REVEALED ANY ALARM. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LWWL PRDGM INS CL EN LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization