BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCCU-CHEK FLEXLINK

    MDR report key: 2943262 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00043
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. THE USED RETURNED TRANSFER SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TRANSFER SET WAS OCCLUDED AT THE CONNECTOR BY INSULIN. A RETENTION SAMPLE COULD NOT BE TESTED BECAUSE THE LOT NUMBER IS UNKNOWN. THE INVOLVED LOT NUMBER 0229480 REFERS ONLY TO THE CANNULA. THE RETURNED USED CANNULAS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET HAD BEEN LEAKING AT THE CONNECTION OF THE INSULIN TUBING AND THE HEADSET. THE LEAKING CAUSED THE PATIENT TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS BETWEEN 300-400 MG/DL. THE ISSUE HAS BEEN ONGOING SINCE (B)(6) 2013. THE PATIENT WOULD CORRECT THE ELEVATED BLOOD GLUCOSE LEVELS BY REPLACING THE INFUSION SET. HE STATED THERE HAVE BEEN MULTIPLE INFUSION SETS THAT HE HAS HAD THE PROBLEM WITH AND THAT THERE APPEARED TO BE SLACK BETWEEN THE CONNECTION OF THE INSULIN TUBING AND THE HEADSET. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28983 DCCU-CHEK FLEXLINK FPA ROCHE HEALTH SOLUTIONS, INC. 00700006959 229480

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN| INSULIN INFUSION PUMP| ACCESSORIES| DATE OF THERAPY: UNK