BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1120247 · Received August 14, 2008

    Report

    Report Number
    2183996-2008-01217
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 31, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HER INFUSION SITE FELL OFF WHILE WORKING IN THE YARD ON A HOT AND HUMID DAY. THE SITE WAS INSERTED IN THE PT'S THIGH. SHE INSERTED A NEW INFUSION SITE AND HER BLOOD GLUCOSE WAS NOT AFFECTED. SHE STATED THAT SHE NOW USES ADDED ADHESIVE WITH THE INFUSION SITE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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