BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK PERSONAL

    MDR report key: 4142993 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29663
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN ATTHIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    WHILE RECEIVING ASSISTANCE WITH CARELINK SOFTWARE, THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 44 MG/DL AT THE TIME OF THE CALL. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603684 CARELINK PERSONAL OYC MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR