BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1993772 · Received January 26, 2011

    Report

    Report Number
    2183996-2011-00056
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HAVING DIFFICULTY REMOVING THE INTRODUCER ON THE INFUSION SET. PATIENT STATED 2 INFUSION SETS LEAKED AND CAUSED ELEVATED READINGS. PATIENT REPORTED SHE IS MANUALLY INSERTING THE INFUSION SET. PATIENT STATED SHE HAD DIFFICULTY PULLING OFF THE NEEDLE BOX ON (B)(6) 2011. PATIENT REPORTED SHE FEELS UPON ATTEMPTING TO PULL THE NEEDLE BOX OFF, THE NEEDLE WAS STILL IN THE BODY AND SCRAPED HER SKIN UPON REMOVAL. PATIENT STATED SHE THOUGHT THE CANNULA WAS IN HER BODY JUST FINE. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL WAS 180 MG/DL BEFORE GOING TO BED. PATIENT STATED SHE WOKE UP AT 7:30 AM WITH A BLOOD GLUCOSE LEVEL OF 170 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 85-120 MG/DL. PATIENT REPORTED SHE BOLUSED FOR BREAKFAST AND FOR CORRECTION AND THEN NOTICED HER SHIRT GOT WET. PATIENT STATED SHE REMOVED THE INFUSION HEADSET AND THE CANNULA WAS BENT. PATIENT REPORTED SHE INSERTED ANOTHER INFUSION HEADSET AND AGAIN THE NEEDLE BOX WAS DIFFICULT TO GET OFF AND THEN THE INFUSION SITE LEAKED. PATIENT STATED SHE ENDED UP INSERTING A DIFFERENT TYPE OF INFUSION HEADSET. PATIENT REPORTED THE INFUSION DEVICE GAVE NO ALERT OR ERROR MESSAGE. PATIENT STATED HER BASAL RATES HAD BEEN CHANGED 2 WEEKS AGO. PATIENT REPORTED SHE DISCARDED THE INFUSION HEADSETS. EDUCATED PATIENT ON PULLING THE NEEDLE BOX OFF. REPLACEMENT INFUSION SETS WERE SENT; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX128

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN