BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2062692 · Received April 12, 2011

    Report

    Report Number
    2032227-2011-00909
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-00908.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS OF 44 MG/DL. THE CUSTOMER WAS DRIVING WHEN HER BLOOD GLUCOSE LEVELS DROPPED, AND SHE GOT INTO AN ACCIDENT. THE CUSTOMER DIDN'T CHECK HER BLOOD GLUCOSE LEVELS PRIOR TO DRIVING BECAUSE SHE HAD JUST EATEN A SNACK AND SHE FIGURED SHE'D BE FINE. THE CUSTOMER ALSO REPORTED BEING IN ANOTHER CAR ACCIDENT AND BEING HOSPITALIZED AFTER EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE DATE OF THE SECOND EVENT WAS NOT PROVIDED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. REVIEWED THE SENSOR ALARM HISTORY, AND FOUND THAT THE CUSTOMER REC'D MULTIPLE LOW ALARMS PRIOR TO THE FIRST CAR ACCIDENT. 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 71 YR Hospitalization