BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945577 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04525
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. 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.

    Additional Manufacturer Narrative · 1

    INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST PER SPECIFICATIONS, RESERVOIR FILLED AND CONNECTED TO NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO INSULIN PUMP AND PERFORMED INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR TO INSULIN PUMP AND PERFORMED CATHETER TIP. RESERVOIR NOT OCCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED SENSOR ERROR AND CALIBRATION ERRORS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 222 MG/DL. ALARMS WERE EXPLAINED AND VERIFIED. SENSOR WAS INSERTED ON (B)(6) 2014 ON THE LOWER RIGHT OF THE ABDOMEN BELOW THE ABDOMEN, APPEARS FULLY INSERTED AND FLAT ON SKIN. ISIG VALUE IS 1.8, EXPLAINED CAUSES. CUSTOMERS INSERTION AND TAPING TECHNIQUE WAS REVIEWED, APPEARS NORMAL. CUSTOMER IS UNABLE TO LOAD DATA TO CARELINK. CUSTOMER INSPECTED TRANSMITTER AND DID TEST PLUG TEST, DEVICE PASSED. CUSTOMER REMOVED SENSOR AND NOTED IT WAS BENT. CUSTOMER WAS ADVISED TO NEVER TREAT BASED ON SENSOR GLUCOSE LEVELS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425049 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG3425

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR