BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3942819 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04281
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. THE NEEDLE COMPLAINT COULD NOT BE CONFIRMED AS ONLY THE SENSOR WAS RETURNED AND NOT THE NEEDLE. THE SENSOR CANNULA WAS FOUND BENT.

    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 SHE HAD INSERTED A SENSOR; IT WAS HURTING HER, SHE TOOK IT OUT AND IT WAS BENT IN AN L SHAPE. HAD ANOTHER SENSOR WHERE THE CONNECTOR DID NOT FIT THE SERTER. CUSTOMER CALLED BACK STATING THE TRANSMITTER IS NOT COMMUNICATING WITH SENSOR, ADVISED TO WAIT THE TWO HOURS BEFORE SELECTING NEW SENOR. BLOOD GLUCOSE LEVEL WAS 214 MG/DL. LATER THAT DAY CUSTOMER CALLED BACK STATING THE INSULIN PUMP WAS ALARMING BAD SENSOR. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 140 MG/DL. SENSOR WAS INSERTED IN THE LOWER RIGHT SIDE OF THE ABDOMEN. ALARM OCCURRED AFTER TWO CONSECUTIVE CALIBRATION ERRORS. CUSTOMER WAS ADVISED TO CHANGE SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419203 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C D244

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR