BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1012848 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00307
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 17, 2008
    Report Date
    February 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED HAVING ISSUES WITH THE INFUSION SET ADHESIVE STICKING TO HIS SKIN. HE STATED "JUST ALL OF A SUDDEN WILL NO LONGER BE STICKING." HE STATED "YESTERDAY EVENING, I GAVE A BOLUS RIGHT BEFORE DINNER AND THE TUBING (CANNULA) WASN'T UNDER THE SKIN." HE STATED THAT THIS HAS HAPPENED 4-5 TIMES IN THE LAST WEEK TO WEEK AND A HALF WITH INFUSION SETS FROM TWO SEPARATE BOXES FROM THE SAME SHIPMENT. THE PATIENT DISCARDED THE BOXES AND WAS UNABLE TO PROVIDE LOT NUMBERS OR EXPIRATION DATES. HE STATED THAT HE IS NOT USING ANY NEW LOTIONS OR SOAPS. HE TYPICALLY USES AN IV PREP WIPE PRIOR TO INSERTING THE INFUSION SITE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED. NO PRODUCT IS AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP