BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3370563 · Received September 26, 2013

    Report

    Report Number
    2183996-2013-01831
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    September 4, 2013
    Report Date
    October 16, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ALL TESTS WERE WITHIN SPECIFICATION. THE COMPLAINED TUBE SET WAS NOT RETURNED FOR INVESTIGATION, SO WITHOUT THE CONCERNED SAMPLE A DETAILED ANALYSIS IS UNFORTUNATELY NOT POSSIBLE. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT SHE HAD BEEN TAKEN TO THE HOSPITAL BECAUSE HER BLOOD GLUCOSE HAD BEEN ELEVATED TO 14-23 MMOL/L (252-414 MG/DL) AND SHE PRESENTED KETONES. THE PATIENT IS PREGNANT. SHE WAS TREATED AT THE HOSPITAL AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. AT THE HOSPITAL, THE STAFF STATED THAT INSULIN WAS LEAKING OUT OF THE MIDDLE OF THE INFUSION TUBING, INSTEAD OF BEING DELIVERED TO THE PATIENT. THE INFUSION SET WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487556 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC 00700006963 5019892

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR Hospitalization| R