BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945825 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04738
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 INSULIN PUMP ALARMED CALIBRATION ERROR. TROUBLE SHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 78 MG/DL. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. ALERT WAS VERIFIED. THE SENSOR WAS INSERTED ON (B)(6) 2014, ON THE LEFT SIDE OF THE ABDOMEN. ALERT OCCURRED WHEN CUSTOMER WOKE UP AND CALIBRATED. ALERT DID NOT OCCUR SHORTLY AFTER PERFORMING A "FIND LOST SENSOR." CUSTOMER WAS ASSISTED WITH INPUTTING ANOTHER FINGER STICK READING. CUSTOMER DECIDED TO WAIT ANOTHER 30 MINUTES BEFORE DOING THE READING. CUSTOMER STATED THE METER INDICATED HIM TO TURN ON AND OFF. NO FURTHER INFORMATION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425751 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR