BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK ULTRAFLEX INFUSION SET

    MDR report key: 1982066 · Received January 14, 2011

    Report

    Report Number
    2183996-2010-02781
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT'S MOTHER REPORTED PATIENT HAS HAD ISSUES WITH LEAKING WHILE ON HIS INFUSION DEVICE. MOTHER REPORTED THAT ON (B)(6) 2010, THE INFUSION SET CRACKED AND LEAKED WHERE THE INFUSION TUBING CONNECTS TO THE INSULIN CARTRIDGE. MOTHER STATED THAT THIS RESULTED IN THE PATIENT HAVING KETONES. MOTHER REPORTED PATIENT'S BLOOD GLUCOSE ON (B)(6) 2010 WENT UP TO 30 MMOL/L (540 MG/DL), THEY BOLUSED, AND THEN 2 HOURS LATER HIS BLOOD GLUCOSE WAS 28.5 MMOL/L (513 MG/DL). PATIENT'S NORMAL GLUCOSE RANGE IS 5-10 MMOL/L (90-180 MG/DL). MOTHER STATED, THEY NOTICED THE INFUSION SET WAS CRACKED AND LEAKING WHERE THE INFUSION TUBING ATTACHES TO THE INSULIN CARTRIDGE. MOTHER REPORTED, THE PATIENT CHANGED HIS INFUSION TUBING AND ABOUT 1.5-2.0 HOURS LATER, HIS BLOOD GLUCOSE WAS BACK TO NORMAL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK ULTRAFLEX INFUSION SET INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 0H075UF

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR INSULIN INFUSION SET| INSULIN