BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1032252 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00558
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON 4/10/2008 THE PT REPORTED THAT THE ADHESIVE OF HIS INFUSION SITES DO NOT STICK TO HIS BODY. HE STATED THAT THE ADHESIVE FALLS OFF WITHIN 1-3 DAYS OF USE. HE REPORTED THAT HE RECENTLY MOVED AND ATTRIBUTES THE ISSUE TO HUMIDITY. HE ALSO REPORTED THAT HE WORKS OUTSIDE AND IT IS "VERY DUSTY AND DIRTY." HE HAS HAD NO CHANGES TO BODY PRODUCTS AND DOES NOT HAVE AN EXCESS OF BODY HAIR AT THE INFUSION SITE. HE USES AN ALCOHOL WIPE TO PREP THE INFUSION SITE PRIOR TO INSERTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. 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 TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS, INC. NA 588705

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN