BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDER INFUSION SET

    MDR report key: 974359 · Received January 4, 2008

    Report

    Report Number
    2183996-2007-01935
    Event Type
    Injury
    Date Received
    January 4, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 21, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 12/21/2007, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE HAD BEEN ELEVATED TO 222-407 MG/DL ALL DAY AND SHE FELT TIRED. HER NORMAL BLOOD GLUCOSE RANGE IS 126-130 MG/DL. SHE STATED THAT THERE MAY HAVE BEEN AIR IN HER INFUSION TUBING BUT IT WAS HARD TO SEE. SHE STATED THAT HER INFUSION SITE HAD BEEN IN PLACE FOR 3 DAYS. SHE WAS ADVISED TO CHANGE HER INFUSION SITE. UPON FOLLOW UP IN 2007, THE PATIENT STATED THAT HER BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDER INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention INSULIN INFUSION PUMP| INSULIN