BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954103 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04686
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CALIBRATION ERRORS WHICH LED TO A BAD SENSOR ERROR. THE BLOOD GLUCOSE READING WAS 112 MG/DL. HE STATED THAT THE ALERT OCCURRED WHILE LAYING IN BED AND AFTER THE INITIALIZATION PERIOD. THE SENSOR WAS NOT EXPIRED. CUSTOMER IS FOLLOWING CALIBRATION RECOMMENDATIONS. HE DID STATED THAT HE ATE DINNER SHORTLY BEFORE CALIBRATING AND WAS ADVISED THAT IT MAY BE A CAUSE OF THE CALIBRATION ERROR. HE ALSO MENTIONED THAT HE HAD SOME BLOOD AT THE SITE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429911 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0419S

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR