BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING

    MDR report key: 6170618 · Received December 13, 2016

    Report

    Report Number
    3012307300-2016-00625
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A CLEO DEVICE, THE SYSTEM HAD LIFTED FROM THE PATIENT'S SKIN INHIBITING INSULIN THERAPY DELIVERY. THE PATIENT STATED THAT SHE STARTED FEELING "LOUSY AND KNEW SOMETHING WAS WRONG". THE PATIENT DISCOVERED THAT HER BLOOD GLUCOSE READING WAS 594 MG/DL. SHE HAD NINE SPARE CLEO SYSTEMS, BUT SHE WAS NOT ABLE TO GET ANY OF THESE TO STICK TO HER SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED. NO FURTHER ADVERSE EVENTS REPORTED AT THIS TIME. SEE MFR: 3012307300-2016-00538, 3012307300-2016-00620, 3012307300-2016-00621, 3012307300-2016-00622 3012307300-2016-00623, 3012307300-2016-00624, 3012307300-2016-00626, 3012307300-2016-00627, 3012307300-2016-00628.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819418 CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other