BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK INSIGHT FLEX

    MDR report key: 10174881 · Received June 19, 2020

    Report

    Report Number
    3011393376-2020-02118
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER OF THE ALLEGED CANNULA WAS NOT PROVIDED. THE PATIENT RETURNED 3 UNUSED CANNULAS WITH LOTS 1271526, 1240520, AND 1240748. THE RETURNED PRODUCT MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. PRODUCT IS NOT EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A DIABETIC KETOACIDOSIS AND POSITIVE KETONE BODIES. THE PATIENT HAD A LOSS OF CONSCIOUSNESS, WAS DEHYDRATED, HAD EXCESSIVE THIRST AND SUFFERED FROM DIZZINESS, VOMITING AND BLURRED VISION. THE USED CANNULA WAS FOUND TO BE BENT. THE PATIENT HAD TO STAY IN THE INTENSIVE CARE UNIT FOR THREE DAYS. THE CUSTOMER WAS TRANSFERRED TO ANOTHER HOSPITAL AND NOW USES AN AC SPIRIT COMBO INSULIN PUMP WITH STEEL NEEDLES FROM THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DECREASED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638528 ACCU-CHEK INSIGHT FLEX SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization UNKNOWN INSULIN| UNKNOWN INSULIN