BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 1050299 · Received May 22, 2008

    Report

    Report Number
    2183996-2008-00759
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    March 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S WIFE REPORTED THAT THE PT'S INFUSION SITES ARE NOT STICKING TO HIS SKIN. SHE STATED THAT FOR THE PAST 2 MONTHS, THE INFUSION SITES HAVE BEEN "LEAKING". HE HAS EXPERIENCED THIS ISSUE WITH 2 BOXES OF INFUSION SETS. THE FIRST BOX OF INFUSION SETS WERE DISCARDED AND THE LOT AND EXPIRATION DATE ARE UNK. SHE REPORTED THAT THE PT EXPERIENCES ELEVATED BLOOD GLUCOSE OF 300-400 MG/DL. THE PT'S WIFE WAS UNABLE TO PROVIDE EXACT BLOOD GLUCOSE VALUES OR DATES OF ELEVATED BLOOD GLUCOSE. SHE REPORTED THAT HE CHANGES THE INFUSION SITE AND BOLUSES TO LOWER HIS BLOOD GLUCOSE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 589740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION PUMP