BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3000784 · Received March 12, 2013

    Report

    Report Number
    2183996-2013-00374
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. INFUSION SET WAS DISCARDED BY PATIENT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE INFUSION SET CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT NO SAMPLE WAS RECEIVED FOR EXAMINATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND CLICK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED PATIENT EXPERIENCING AN INCIDENT OF A LEAKY INFUSION SET. PATIENT STATED THE LEAK OCCURRED WHERE THE INFUSION SET TUBING CONNECTS TO THE INFUSION SET. PATIENT REPORTED THE LEAK WAS DISCOVERED WHEN THE PATIENT FELT INSULIN DRIP ONTO HIS SIDE DURING A BOLUS. PATIENT WEARS THE INFUSION DEVICE IN A CASE ON HIS BELT. PATIENT REPORTED A CLICK WAS HEARD WHEN CONNECTING THE TUBING TO THE INFUSION SET. INFUSION SET IS INSERTED MANUALLY. PATIENT STATED AFTER THE PATIENT DISCOVERED THE LEAK, HE DISCONNECTED THE INFUSION SET FORM THE TUBING AND RECONNECTED THEM; AND THEN HE DELIVERED A SMALL BOLUS. PATIENT REPORTED THE LEAK DID NOT RETURN. INFUSION SET AND TUBING HAS BEEN DISCARDED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. SENDING INSERTION ASSIST DEVICE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103147 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA 223480

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR INSULIN PUMP (HUMALOG)| LOSARTAN| CLOPIDOGREL| FENOFIBRATE| TAMSULOSIN| CLONAZEPAM| KRILL OIL| NORVASC| CENTRAVIT MULTIVITAMIN| IRON| ATENOLOL| HUMALOG BY SYRINGE| HUMALOG INSULIN| ASPIRIN| INSULIN SYRINGE (HUMALOG)| VITAMIN D| CYMBALTA