BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1030580 · Received April 15, 2008

    Report

    Report Number
    2183996-2008-00531
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED HE RECEIVED AN OCCLUSION ERROR MESSAGE ON HIS INSULIN INFUSION DEVICE THIS MORNING WHILE HE WAS TRYING TO BOLUS 15-20 UNITS OF INSULIN. HE SAID, HE CLEARED THE MESSAGE BY CHANGING HIS INSULIN INFUSION SET. HE STATED HE HAS BEEN REPLACING HIS INFUSION SET ON A DAILY BASIS. DURING TROUBLESHOOTING, THE PT DESCRIBED HIS PROCESS FOR CHANGING INFUSION SETS AND STATED HE INSERTS THE HEADSET AT A 20 DEGREE ANGLE. THE PT WAS ADVISED TO INSERT THE HEADSET SLOWLY AND AT A 45 DEGREE ANGLE. THE PT STATED HE ROTATES HIS SITE ON HIS ABDOMEN AND ALWAYS SELECTS A NEW SITE 2 INCHES FROM HIS PREVIOUS SITE. HE STATED HE HAS NEVER NOTICED ANY KINKING OR A BENT CANNULA. THE PT STATED HE DISCARDED THE INFUSION SET AT ISSUE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE 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 593499

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP