BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDERLINK

    MDR report key: 2143702 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01588
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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

    THE PATIENT'S MOTHER REPORTED THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE WHILE USING THE INFUSION SET. AFTER THE SECOND DAY OF USE THE PATIENT'S BLOOD GLUCOSE MEASURED OVER 17.3 MMOL/L (311 MG/DL) AT 2:15AM AND THE MOTHER ADMINISTERED 3.2, AND 2.0 UNITS OF INSULIN. AT 3:16AM HIS BLOOD GLUCOSE MEASURED 12.6 MMOL/L (227 MG/DL), 10.9 MMOL/L (196 MG/DL) AT 4:16 AM, 11.8 MMOL/L (212 MG/DL) AT 6:00AM, AND 14.4 MMOL/L (259 MG/DL), TIME UNKNOWN. THE MOTHER THEN RECOGNIZED THAT INSULIN WAS LEAKING BETWEEN THE INFUSION SET TUBING AND LUER. THE PATIENT CHANGED THE INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE AND HIS BLOOD GLUCOSE DECREASED. SHE STATED THAT WHEN THE PATIENT USED THE 30CM INFUSION SET HE HAD NO ISSUES. WHEN THE PATIENT USED THE 60CM INFUSION SET INSULIN LEAKED BETWEEN THE INFUSION TUBING AND LUER. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDERLINK INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 646459

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR INSULIN INFUSION PUMP| INSULIN