BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN REAL-TIME MONITIOR

    MDR report key: 4240597 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-34736
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Description of Event or Problem · 1

    WHILE REQUESTING ASSISTANCE WITH LOST SENSOR ALERTS, CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 41 MG/DL THE NIGHT BEFORE THE CALL. CUSTOMER TREATED WITH GLUCOSE TABLETS AND FOOD. CUSTOMER ALSO REPORTED THAT SHE OFTEN EXPERIENCES LOW BLOOD GLUCOSE LEVELS AT NIGHT. CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT DURING THE CALL. BLOOD GLUCOSE LEVEL WAS 118 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723778 GUARDIAN REAL-TIME MONITIOR CGM MDS MEDTRONIC MINIMED CSS7100NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR