BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3242211 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01334
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 4, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EXAMINATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND LUER RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HE NOTICED INSULIN LEAKING FROM THE LUER LOCK OF HIS INFUSION SET. HE STATED THAT THE LUER HAD LOOSENED FROM THE INFUSION DEVICE. HIS BLOOD GLUCOSE LEVEL WAS ELEVATED AND HE THINKS IT WAS DUE TO THE INSULIN LEAK AT THE LUER LOCK. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS DISCARDED BY THE PATIENT. THE PATIENT WAS SENT COMPLIMENTARY INFUSION SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344324 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 5019858

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR AVIVA COMBO METER| APIDRA INSULIN| FLEX PEN (APEDRA)| APIDRA INSULIN