BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2233999 · Received August 31, 2011

    Report

    Report Number
    2032227-2011-02216
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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. MFG. RPT 1 OF 2, MEDWATCH REPORT # 3004209178-2011-82788.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING A DISCREPANCY BETWEEN THE SENSOR GLUCOSE AND THE BLOOD GLUCOSE READING. THE CUSTOMER STATED THAT THE SENSOR KEPT READING HIGH THE DAY BEFORE. THE CUSTOMER TREATED HIS GLUCOSE LEVEL BASE ON THE SENSOR VALUES. THE CUSTOMER'S BLOOD GLUCOSE DROPPED AND PARAMEDICS WERE CALLED. IT WAS STATED THAT THE CUSTOMER USES A SINGLE METER TO CALIBRATE. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE CUSTOMER INSERTS AT 45 DEGREES. ADVISED THE CUSTOMER TO CALIBRATE FOUR TIMES A DAY WHEN HIS BLOOD GLUCOSE IS STABLE FOR MORE ACCURATE READINGS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C E131

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization