BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103477 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26379
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 THAT THE INSULIN PUMP KEEPS GOING INTO THRESHOLD SUSPEND AND CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS ACTUALLY HIGH. CUSTOMER WAS NOT ABLE TO CALIBRATE WITH THE READINGS SO FAR APART. CUSTOMER RECEIVED A CALIBRATION ERROR. CUSTOMER WAS TAKING PENICILLIN BECAUSE OF TOOTH ACHE. CURRENT BLOOD GLUCOSE VALUE WAS 186 MG/DL, SENSOR GLUCOSE VALUE 70 MG/DL. CUSTOMER WAS ADVISED THAT THE PENICILLIN CAN AFFECT THE GLUCOSE READINGS, BUT SHE WILL NEED TO SPEAK WITH THE DOCTOR. CUSTOMER DID CALIBRATE WITH A BLOOD GLUCOSE VALUE OF 313 MG/DL THE NIGHT BEFORE AND THE SENSOR WAS READING 202 MG/DL. CUSTOMERS ALSO MENTION THE INSULIN PUMP HAS A CRACK. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585260 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG039Q8

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR