BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080238 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00802
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HYPERGLYCEMIA DUE TO THE INFUSION SETS. BLOOD GLUCOSE ELEVATED TO 300-350 MG/DL, AND NORMAL BLOOD GLUCOSE IS 100-120 MG/DL. PT FELT TERRIBLE AND BOLUSED TO CORRECT HYPERGLYCEMIA. THERE WERE NO ISSUES WITH THE PREPARATION OF THE INFUSION SET. AT TIMES, THE INFUSION SET DID NOT INSERT PROPERLY. THERE WAS NO INSULIN LEAKAGE. INFUSION SET INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. THERE WERE NO ISSUES REMOVING THE INFUSION SET. THIS FIRST OCCURRED 3 WEEKS PRIOR TO THE REPORT. BLOOD GLUCOSE WAS WITHIN NORMAL RANGE AT THE TIME OF THE REPORT. PRODUCT WAS REPLACED. NO PRODUCT WAS REQUESTED FOR EVALUATION. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN INFUSION DEVICE| INSULIN