BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4120059 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29368
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 MEDWATCH REPORT # 2032227-2014-29367.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND THAT THERE WERE DISCREPANCIES BETWEEN THE SENSOR AND BLOOD GLUCOSE READINGS. THE BLOOD GLUCOSE READING WAS BETWEEN 50 AND 60 MG/DL, WHICH THE CUSTOMER TREATED BY EATING. THE CUSTOMER STATED THAT THE BLOOD GLUCOSE LEVELS RETURNED TO NORMAL, THEN RAN HIGH IN THE MORNING, WITH A BLOOD GLUCOSE READING OF 179 MG/DL. SHE PERFORMED A BOLUS AND STATED THAT THE SENSOR KEPT ALERTING THAT SHE HAD LOW BLOOD GLUCOSE WHEN SHE DID NOT. SHE REPORTED THAT SHE TURNED OFF THE SENSOR FEATURE, AND WHEN SHE WENT TO REMOVE THE SENSOR, SHE FOUND THAT THE SENSOR NEEDLE HAD NOT ENTERED THE INSERTION SITE. SHE NOTED BLEEDING AT THE SITE. THE CALL WAS ENDED AND SEVERAL ATTEMPTS TO REACH THE CUSTOMER WERE UNSUCCESSFUL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597457 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR