BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1973899 · Received January 20, 2011

    Report

    Report Number
    2183996-2011-00039
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    October 15, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD & RESULT: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ONGOING CONCERN WITH INSULIN LEAKING FROM THE INFUSION SITE. SHE TRIED 3 DIFFERENT CANNULA LENGTHS, AND THE LEAKING CONTINUED. PT HAD TO CHANGE HER INFUSION SITE EVERY 8-9 HOURS. BLOOD GLUCOSE ELEVATED TO 520 MG/DL THE NIGHT BEFORE REPORT. IT WAS 460 MG/DL THE NEXT MORNING. TARGET BLOOD GLUCOSE IS 100 - 130 MG/DL. PT TREATS ELEVATED BLOOD GLUCOSE WITH BOLUSES AND INSULIN INJECTIONS, AND THE INFUSION SITE WILL LEAK DURING BOLUS DELIVERY. ADAPTER, INFUSION SET, AND CARTRIDGES ARE USED PER SPECIFICATION. THIS CONCERN STARTED WHEN PT FIRST USED THIS TYPE OF INFUSION SET IN (B)(6) 2010. PT REC'D TREATMENT AT THE EMERGENCY ROOM ON (B)(6) 2011 DUE TO HYPERGLYCEMIA AND KETOSIS DUE TO A LEAKY INFUSION SET. BLOOD GLUCOSE WAS 367 MG/DL, AND PT WAS IN THE ER FOR 5 HOURS. SHE WAS TREATED WITH IV FLUIDS AND AN INJECTION OF LONG ACTING INSULIN. PT REPORTED SHE COULD HAVE GIVEN TREATMENT FOR HYPERGLYCEMIA HERSELF; HOWEVER, PHYSICIAN ADVISED TO GO TO THE ER IF SHE WAS POSITIVE FOR KETONES. BLOOD GLUCOSE LOWERED TO 189 MG/DL BY THE TIME SHE WAS RELEASED. CLINICAL TRAINER MET WITH PT ON (B)(6) 2011 AND OBSERVED HER INSERTION TECHNIQUE. SHE INSERTED THE INFUSION SET CORRECTLY. PT STARTED A STAINLESS STEEL INFUSION SET DURING MEETING AND EXPERIENCED NO FURTHER LEAKING OF INSULIN OR ELEVATED BLOOD GLUCOSE. SHE DOES NOT ENGAGE IN EXTENSIVE PHYSICAL ACTIVITY AND DOES NOT MOVE WHEN SLEEPING AT NIGHT. THE INFUSION ADHESIVE ADHERES WELL TO HER SKIN. INFUSION SETS THAT LEAKED INSULIN WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    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 GWX075

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R INSULIN INFUSION DEVICE| INSULIN