BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 2972054 · Received February 21, 2013

    Report

    Report Number
    2032227-2013-00681
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    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 3004209178-2013-91202.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS IN A CAR ACCIDENT WHEN HE EXPERIENCED LOW BLOOD GLUCOSE LEVELS WHILE DRIVING. THE CUSTOMER STATED THAT HE RAN INTO A TELEPHONE POLE, AND WAS TAKEN TO THE HOSPITAL BY THE PARAMEDICS. THE CUSTOMER UPLOADED THE INSULIN PUMP TO CARELINK, AND FOUND THAT THE INSULIN PUMP HAD ALARMED HIM OF HIS LOW BLOOD GLUCOSE LEVELS. HOWEVER THE CUSTOMER STATED THAT HE NEVER HEARD THE ALARMS. THE CUSTOMER ASKED IF THERE WAS A WAY TO MAKE THE ALARMS LOUDER. ADVISED THE CUSTOMER THAT THE AUDIO ALERTS CAN BE SET TO BEEP LONG. THE CUSTOMER UNDERSTOOD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76966 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization