BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1030135 · Received April 15, 2008

    Report

    Report Number
    2183996-2008-00529
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    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

    THE PATIENT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 414 MG/DL WITH HIS NORMAL RANGE BEING 160-165 MG/DL. HE STATED HIS SYMPTOMS WERE BLURRED VISION AND A BAD TASTE SENSATION AND HE CORRECTED HIS READING BY INJECTING 25 UNITS OF INSULIN. DURING TROUBLESHOOTING, THE PATIENT STATED HE FELT THE PROBLEM WAS CAUSED BY HIS INFUSION HEADSET. HE STATED IT HAD BEEN IN USE FOR 4 DAYS. THE PATIENT WAS ADVISED TO CHANGE HIS INFUSION HEADSET EVERY 3 DAYS AND THE INFUSION SET TUBING EVERY 6 DAYS. HE SAID THERE WAS NO DAMAGE OR KINKED CANNULA ON THE EXISTING INFUSION SET. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

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