BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D

    MDR report key: 3113206 · Received May 15, 2013

    Report

    Report Number
    2183996-2013-00859
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    July 24, 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

    THE 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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE INFUSION SETS FROM THE SAME BOX THAT LEAKED INSULIN NEAR THE LUER AND ADAPTER. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215667 ACCU-CHEK RAPID-D INSULIN INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH 00700006932 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR