BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LWWS PRDGM INS SK EN LN

    MDR report key: 1931044 · Received December 8, 2010

    Report

    Report Number
    2032227-2010-83374
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. PRIOR TO THE EVENT, THE CUSTOMER WOKE FEELING DIZZY AND HAD A BLOOD GLUCOSE OF 23 MMOL/L. THE CUSTOMER WENT TO WORK, THEN LOST CONSCIOUSNESS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 33 MMOL/L WHEN THE PARAMEDICS ARRIVED. THE CUSTOMER'S HEALTHCARE PROFESSIONAL REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization