BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK INFUSION SET

    MDR report key: 2012966 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00454
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 EXPERIENCING AN ELEVATED BLOOD GLUCOSE LEVEL OF 20 MMOL/L (360 MG/DL) WITH THE LAST 2 INFUSION SETS. PT CHANGED THE INFUSION SET AND BLOOD GLUCOSE RETURNED TO NORMAL RANGE OF 7-8 MMOL/L (126-144 MG/DL). PT THINKS THERE IS INSULIN LEAKING. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN