BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3070751 · Received April 22, 2013

    Report

    Report Number
    2183996-2013-00723
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 18, 2013
    Report Date
    July 19, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION SET LEAKED INSULIN DURING BOLUS DELIVERY. THE INFUSION SET HAD BEEN IN USE FOR 1 DAY AND WAS LOCATED ON HER ABDOMEN. THE HEADSET WAS INSERTED WITH AN INSERTION DEVICE, AND SHE DOES PRACTICE SITE ROTATION. THE INFUSION TUBE DID NOT APPEAR LOOSE OR BROKEN. THE HEADSET WAS REMOVED, AND THE CANNULA WAS NOT BENT. SHE CHANGED THE INFUSION SET, AND THE ISSUE WAS RESOLVED. THE ALLEGED INFUSION SET WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171162 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA 5019445

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR APEIDRA INSULIN| JANUMET 50/1,000