BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3933438 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03872
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOST SENSOR ALERTS. CUSTOMER STATED THAT THE WRONG TRANSMITTER ID WAS NOT PROGRAMMED IN THE INSULIN PUMP. SHE STATED THAT THE INSULIN PUMP WAS NOT COMMUNICATING WITH THE TRANSMITTER. THE LOST SENSOR ALERT WAS REOCCURRING. CUSTOMER FOUND THAT THE LOST SENSOR ALARM OCCURRED DUE TO THE SENSOR FALLING OUT. THE BLOOD GLUCOSE READING WAS 149 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411141 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C L213

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR