BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1912684 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83272
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE CUSTOMER REFUSED TO BE TAKEN TO THE HOSPITAL. THE REPORTED BLOOD GLUCOSE READING WAS 20 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER USES QUICK-SET INFUSION SETS. NO INFUSION SITE OR SET PROBLEMS WERE NOTED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention