BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1915818 · Received November 30, 2010

    Report

    Report Number
    2032227-2010-83303
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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

    THE CUSTOMER REPORTED RECEIVING A NO DELIVERY ALARM DURING BOLUS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 480MG/DL. THE CUSTOMER STATED THAT HE RECEIVED THE ALARMS FOR A COUPLE OF DAYS. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization