BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4190472 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-40311
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR PASSED WITH ACCURATE READINGS. NO NEEDLE COMPLAINT COULD BE CONFIRMED AS THE CUSTOMER RETURNED THE SENSOR WITHOUT THE NEEDLE. THE CANNULA WAS FOUND BENT. IT COULD NOT BE CONFIRMED THAT THE SENSOR WAS RECEIVED IN SAID CONDITION DUE TO THE CUSTOMER RETURNING IT OPENED AND USED.

    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

    THE CUSTOMER REPORTED THAT SHE WAS RECEIVING CALIBRATION ERRORS AND UPON REMOVING HER SENSOR, THE TIP WAS BENT AND THERE WAS A SEPARATION ABOVE THE BEND. THE CUSTOMER DECLINED TROUBLESHOOTING. HER BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666937 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C F134

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR