BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX

    MDR report key: 3103238 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00830
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 29, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE HEAD SET CANNOT BE VERIFIED, THE HEAD SET MEETS PRODUCT SPECIFICATIONS. RESULT THE TWO USED AND FOUR UNUSED RETURNED HEAD SETS WERE VISUALLY INSPECTED AND TESTS FOR FLOW AND TIGHTNESS WERE PERFORMED. ALL SINGLE PACKAGES ARE DENTED. TEST RESULTS WERE WITHIN SPECIFICATIONS.. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT 4 CANNULAS FROM THIS BOX ARE LEAKY. PATIENT STATED AFTER BOLUSING, THE SELF-ADHESIVE IS WET. PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVEL OF APPROXIMATELY 380 MG/DL. PATIENT REPORTED TAKING CORRECTION VIA THE INFUSION DEVICE; NO SUCCESS AND THE SELF-ADHESIVE WAS LEAKY. PATIENT STATED WHEN THE CANNULA WAS REMOVED HE NOTICED THAT THE SOFT CANNULA WAS BENT. PATIENT REPORTED THAT WITH CANNULAS FROM ANOTHER LOT NUMBER THERE WERE NO PROBLEMS. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203666 ACCU-CHEK ® ULTRAFLEX INSULIN INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. 00700008650 227231

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR