BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2151657 · Received June 28, 2011

    Report

    Report Number
    2183996-2011-01848
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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, PATIENT'S MOTHER-IN-LAW REPORTED THE PATIENT HAS BEEN HAVING ISSUES WITH ELEVATED BLOOD GLUCOSE LEVELS DUE TO HIS TUBING LENGTHS BEING TOO SHORT. ADVISED THE INFUSION SETS WILL VARY IN TUBING LENGTH. ADVISED TO HAVE PATIENT REQUEST LONGER TUBING WHEN HE ORDERS SUPPLIES. PATIENT'S MOTHER-IN-LAW STATED THE PATIENT EXPERIENCED A BLOOD GLUCOSE READING AS HIGH AS 437 MG/DL WHICH REQUIRED HIM TO GO TO THE HOSPITAL. ON FOLLOW UP CALL ON (B)(6) 2011, PATIENT REPORTED HE DIDN'T HAVE ANY ISSUES WITH THE INFUSION DEVICE. PATIENT STATED THE ISSUE HE WAS HAVING WAS DUE TO HIS INFUSION SET TUBING BEING TOO SHORT. PATIENT REPORTED THE SHORT TUBING BECOMES DETACHED WHILE HE IS ROLLING AROUND IN BED WHILE SLEEPING. PATIENT STATED HE DIDN'T KNOW HE WAS DETACHED FROM HIS INFUSION SITE UNTIL HE WORK UP THE NEXT MORNING, WHICH CAUSED HIS ELEVATED BLOOD GLUCOSE CONCERNS. PATIENT REPORTED HE RECEIVED READINGS AS HIGH AS 320 MG/DL THAT MORNING. PATIENT STATED HE HAD CHEST PAINS, FELT DIZZY AND WAS EXTREMELY DEHYDRATED. PATIENT REPORTED HE DECIDED TO GO TO THE HOSPITAL. PATIENT STATED HE DID NOT TRY TO TREAT HIMSELF BECAUSE THE CHEST PAINS WERE TOO BAD. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS AROUND 100-150 MG/DL. PATIENT REPORTED THE INFUSION SITE WAS NOT FALLING OFF OF HIS BODY, BUT THE INFUSION SET TUBING WAS BECOMING DISCONNECTED FROM THE INFUSION SITE. ADVISED PATIENT TO DISCONTINUE USE OF THE INFUSION SETS. PATIENT STATED HIS BLOOD GLUCOSE READINGS WERE IN THE 400'S MG/DL WHEN HE ARRIVED AT THE HOSPITAL. PATIENT REPORTED THEY GAVE HIM AN INSULIN SHOT AND AN IV OF UNKNOWN CONTENTS. PATIENT STATED HE WAS NOT SURE IF IT WAS JUST FLUID BECAUSE HE WAS DEHYDRATED OR MEDICATION. PATIENT REPORTED HE WAS IN THE HOSPITAL FROM 9 AM - 5 PM AND THEN RELEASED. PATIENT STATED HIS BLOOD GLUCOSE LEVEL HAS RETURNED BACK TO NORMAL BECAUSE HE IS USING A DIFFERENT TYPE OF INFUSION SET NOW. PATIENT DISCARDED THE ALLEGED INFUSION SET. 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 LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX164

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R INSULIN| INSULIN INFUSION PUMP