BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-C RAPID-D/LINK

    MDR report key: 3151435 · Received June 7, 2013

    Report

    Report Number
    2183996-2013-01035
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    July 11, 2013
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE INFUSION SET CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT THE FIFTEEN RETURNED UNUSED SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT FOR 1 ½ MONTHS, THE INFUSION SET HAS BEEN LEAKY BETWEEN THE CANNULA HOUSING AND SELF-ADHESIVE. PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS UP TO 300 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED TAKING CORRECTION VIA THE INFUSION DEVICE AND PEN. PATIENT REPORTED CHANGING THE NEEDLE AFTER 2 DAYS AND THE INFUSION SET TUBING AFTER 3-4 DAYS. PATIENT DISPOSED OF THE ALLEGED INFUSION SET. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE UNUSED INFUSION SETS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252500 A-C RAPID-D/LINK INSULIN INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH 00700006928 32432222

    Patients

    Seq Age Sex Outcome Treatment
    1