BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL

    MDR report key: 4112209 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-22251
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 14, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED A LOW BLOOD GLUCOSE OF 27 MG/DL. SHE DECLINED TO TROUBLESHOOT FOR THE PAST LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592208 CARELINK PERSONAL INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR