BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1432869 · Received May 7, 2009

    Report

    Report Number
    2183996-2009-00630
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    April 6, 2009
    Report Date
    April 6, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT REPORTED THAT WHILE AT THE AIRPORT HIS INFUSION TUBING BECAME DISCONNECTED FROM HIS INFUSION SITE. HE STATED THAT HE NOTICED WHILE INITIALLY CONNECTING THE TUBING TO THE HEADSET, THAT THE CONNECTION WAS NOT SECURE. HE RECONNECTED THE INFUSION TUBING TO THE HEADSET AND HAD NO FURTHER ISSUES. HE STATED THAT HE CHANGES HIS INFUSION SITE EVERY 3 DAYS AND THE INFUSION TUBING EVERY 6 DAYS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 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 NA 608657

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR INSULIN| INSULIN INFUSION PUMP