BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2210143 · Received August 3, 2011

    Report

    Report Number
    2032227-2011-01924
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    March 23, 2011
    Report Date
    July 20, 2011
    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 UNKNOWN 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 THAT HE WAS HOSPITALIZED AFTER EXPERIENCING PAIN, SKIN IRRITATION AND INFECTION AT THE INSERTION SITE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 147 MG/DL AT THE TIME OF THE EVENT. FOUND THAT THE CUSTOMER HAD BEEN RECENTLY USING EXPIRED SENSORS. ADVISED THE CUSTOMER THAT EXPIRED SENSORS SHOULD NOT BE USED, AND THAT EXPIRED SENSORS CANNOT BE REPLACED. THE CUSTOMER WAS DISSATISFIED, AND ENDED THE CALL. THE CUSTOMER WAS CALLED SEVERAL TIMES FOR MORE INFORMATION REGARDING THE HOSPITALIZATION, BUT THE CUSTOMER DID NOT WANT TO DISCUSS IT FURTHER.

    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 K290

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization