BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1932876 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83451
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE CANNOT RECALL MORE DETAILS ON HER VISIT TO THE HOSPITAL. TROUBLESHOOTING WAS NOT PERFORMED, AND THE CUSTOMER MENTIONED USING HUMULIN 500 IN THE INSULIN PUMP. ADVISED THE CUSTOMER THAT IS NOT RECOMMENDED FOR USE WITH THE DEVICE. THE CUSTOMER STATED THAT SHE WAS INSTRUCTED BY HER PHYSICIAN DUE TO BEING INSULIN RESISTANT. THE CUSTOMER WAS ON BACK UP PLAN UNTIL SHE SEES HER ENDOCRINOLOGIST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization