BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974102 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05271
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SENSOR IS VERY INACCURATE. CUSTOMER REPORTED SEVERAL PROBLEMS. CUSTOMER STATED SHE WAS HAVING TROUBLE KEEPING THE SENSOR ON. CUSTOMER HAS TRIED ANTIPERSPIRANT AND TEGADERM, IT STILL FALLS OFF. SHE USED SKIN TAC AND CUSTOMER WAS HIGHLY ALLERGIC TO IT. CUSTOMER STATED THE SENSORS DID NOT LAST THE SIX DAYS. CUSTOMER REPORTED THE SENSOR GLUCOSE READING WAS OFF BY 50 TO 100 POINTS. CUSTOMER REPORTED THAT SHE TURNED OFF THE ALARMS AT NIGHT. CUSTOMER'S SENSOR GLUCOSE WAS 129 MG/DL AND BLOOD GLUCOSE WAS 274 MG/DL, TREATED WITH THE INSULIN PUMP. CUSTOMER INSERTED THE SENSOR ON THE LEFT SIDE OF THE NAVEL. CUSTOMER CAN PINCH AN INCH OF TISSUE. NO ISSUES WITH INSERTION OR SITES. UNABLE TO TROUBLESHOOT CUSTOMER HUNG UP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450681 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR