BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK PLUS INFUSION SET

    MDR report key: 7464012 · Received April 26, 2018

    Report

    Report Number
    3011393376-2018-01868
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 13, 2018
    Report Date
    July 25, 2018
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT PATIENT WAS USING 6MM CANNULAS BEFORE BUT DUE TO HIGH BLOOD GLUCOSE LEVELS AFTER CHILD'S WEIGHT INCREASED, THEY CHANGED TO 8MM CANNULAS WHICH WORKED FINE SINCE LAST YEAR. ONLY AFTER RECEIVING THE LAST SUBMISSION OF 3 PACKAGES SETS AND 3 PACKAGES CANNULAS LOT 1203024 AND LOT 1193315 THEY CONTINUE TO HAVE PROBLEMS. THE LOT NUMBER OF THE SUSPECT DEVICE IS STILL UNKNOWN

    Description of Event or Problem · 1

    CALLER REPORTEDLY EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS ALTHOUGH WAS RECEIVING BOLUSES; REQUIRED HOSPITALIZATION. TREATMENT RECEIVED IS UNKNOWN. CALLER ALLEGES THE INFUSION SETS ARE THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS. REQUESTED RETURN OF THE ALLEGED INFUSION SETS AND REPLACEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308309 ACCU-CHEK ® FLEXLINK PLUS INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R