BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1071415 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00998
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 HE BECAME "DISCONNECTED" FROM HIS INFUSION DEVICE AND HIS BLOOD GLUCOSE WAS ELEVATED. HE STATED THAT HE REATTACHED THE INFUSION TUBING AND PERFORMED A BOLUS, BUT HIS BLOOD GLUCOSE REMAINED ELEVATED. HE ATTACHED A NEW INFUSION TUBING AND WAS ASSISTED WITH PRIMING. WHEN ASKED FOR DETAILS OF ELEVATED BLOOD GLUCOSE THE PT STATED "I'LL HAVE TO GET BACK TO YOU LATER". UPON F/U FIVE DAYS LATER, THE PT STATED THAT HE WAS ABLE TO RESOLVE THE ISSUE AND HAD NO FURTHER CONCERNS. 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 Required Intervention INSULIN| INSULIN INFUSION PUMP