BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1915786 · Received November 30, 2010

    Report

    Report Number
    2032227-2010-83296
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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

    THE CUSTOMER CALLED TO REQUEST ASSISTANCE IN SETTING THE BOLUS WIZARD. THE CUSTOMER WAS USING A BLOOD GLUCOSE METER AND WANTED IT TO COMMUNICATE WITH THE DEVICE. DAYS LATER, THE CUSTOMER CALLED BACK AND STATED THAT SHE IS IN THE HOSPITAL. THE CUSTOMER STATED THAT SHE WAS TRYING TO USE HER OLD INSULIN PUMP AND FEW HOURS LATER, HER BLOOD GLUCOSE WENT UP TO 500 MG/DL. THE PARAMEDICS WERE CALLED AND TOOK THE CUSTOMER TO THE HOSPITAL FOR DIABETES KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. RAN A SELF TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization