BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDERLINK INFUSION SET

    MDR report key: 2172399 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01765
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 27, 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. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, SHE THINKS, THE LUER CONNECTION IS NOT OKAY. PT STATED, THE CONNECTION SMELLS OF INSULIN. PT REPORTED, SHE THINKS, THE LUER IS LEAKY. PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS. PT STATED ON (B)(6) 2011, HER BLOOD GLUCOSE LEVEL AT 11:29 PM WAS 228 MG/DL. PT REPORTED ON (B)(6) 2011, HER BLOOD GLUCOSE LEVEL AT 1:00 AM WAS 368 MG/DL AND SHE ONLY CHANGED THE INFUSION SET TUBING; AT 7:53 AM HER BLOOD GLUCOSE WAS 289 MG/DL AND SHE TOOK CORRECTION VIA THE INFUSION DEVICE AND ATE; AND AT 12:57 PM, HER BLOOD GLUCOSE LEVEL WAS 311 MG/DL. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDERLINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 625593

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INSULIN INFUSION PUMP| INSULIN