BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082068 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01084
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 9, 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
    AZ, 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 PT REPORTED HIS INSULIN INFUSION SETS ARE NOT PROPERLY ADHERING. HE STATED THAT FIVE DAYS PRIOR, AND ON SEVERAL OTHER OCCASIONS HIS INFUSION SET CAME OFF. HE SAID ALL THE SETS WERE FROM THE SAME BOX, BUT COULD NOT VERIFY THE LOT NUMBER OR EXPIRATION DATE AS HE WAS AT WORK. THE PT STATED HE USES IV PREP WIPES AND INSERTS HIS INFUSION SETS INTO CLEAN SKIN. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED. NO PRODUCT WILL BE RETURNED 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 INFUSION PUMP| INSULIN