BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK PERSONAL

    MDR report key: 4123621 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29689
    Event Type
    Injury
    Date Received
    September 26, 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 Location
    FL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE EXPERIENCED LOW BLOOD GLUCOSE OF 48 MG/DL. CUSTOMER STATED HER BLOOD GLUCOSE WENT LO DUE TO WORKING OUT; SHE ATE TO TREAT. CUSTOMER STATED THAT SHE COULD NOT LOG INTO HER CARELINK ACCOUNT AND SHE IS NOT ABLE TO UPLOAD DATA TO HER COMPUTER BECAUSE THE USB DOES NOT FIT. CUSTOMER WILL BUY A CONNECTOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600299 CARELINK PERSONAL MRZ OYC MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR