BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 2981206 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00262
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 12, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. LOT/SERIAL NUMBER IS NOT AVAILABLE. THEREFORE NO INVESTIGATION WAS POSSIBLE. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT WAS AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED HE HAS EXPERIENCED LEAKING AROUND THE SELF-ADHESIVE AT HIS INFUSION SITE. HE DISCOVERED THE LEAK WHEN HE CHECKED HIS BLOOD GLUCOSE LEVEL AND FOUND THAT IT WAS ELEVATED TO 300 MG/DL. HIS TARGET LEVEL IS AROUND 125 MG/DL. THE PATIENT ATTEMPTED TO BOLUS TO CORRECT THE ELEVATED LEVEL. FOLLOW-UP WITH THE PATIENT REVEALED THAT HIS BLOOD GLUCOSE LEVEL RETURNED TO NORMAL AFTER CHANGING THE INFUSION SET. THE PATIENT STATED THAT HE DID NOT THINK THAT THE LEAKING WAS DUE TO POOR ABSORPTION, BUT WAS PRODUCT RELATED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS DISCARDED; THEREFORE, NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83348 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR INSULIN