BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L

    MDR report key: 1821182 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82447
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS LAST NIGHT, AND HER SENSOR DID NOT GIVE HER AN ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE LEVELS AS LOW AS 30 MG/DL, WITH A SENSOR READING OF 100 MG/DL. THE PARAMEDICS WERE CALLED TO HER HOME, BUT THE CUSTOMER WAS NOT HOSPITALIZED. ADVISED THE CUSTOMER ON PROPER CALIBRATION, AS SHE WAS ONLY CALIBRATING TWICE A DAY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L GLUCOSE SENSOR MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention