BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070247 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01109
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A COMPLAINT AGAINST THE INFUSION SET. FOLLOW-UP WAS COMPLETED ON (B)(6) 2011, AND PATIENT REPORTED THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE AND WAS HOSPITALIZED DUE TO A BENT INFUSION CANNULA. ON (B)(6) 2011, BLOOD GLUCOSE ELEVATED TO 300 MG/DL, AND NORMAL BLOOD GLUCOSE IS NEAR 90 MG/DL. PATIENT BOLUSED THROUGH THE INFUSION DEVICE, BUT HER BLOOD GLUCOSE DID NOT DECREASE. PATIENT FELT ILL AND CONTACTED A NURSE FOR MEDICAL ADVISE. PATIENT WAS TOLD TO INJECT 15 UNITS OF INSULIN VIA SYRINGE. PATIENT DID THIS, BUT BLOOD GLUCOSE ELEVATED TO "HI" MG/DL 30 MINUTES LATER. PATIENT WAS TRANSPORTED TO THE HOSPITAL BY EMT. BLOOD GLUCOSE WAS 550 MG/DL WHEN SHE ARRIVED AT THE HOSPITAL, AND PATIENT WAS TREATED WITH INSULIN. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. SHE CHANGED THE INFUSION SET WHEN SHE RETURNED HOME, AND SHE NOTICED THE CANNULA WAS BENT. PATIENT SWITCHED TO INJECTION THERAPY UNTIL SHE RECEIVED A DIFFERENT TYPE OF INFUSION SET. THE HEADSET WAS INSERTED LESS THAN 1 DAY BEFORE THE EVENT. THERE WAS NO INSULIN LEAKAGE. PATIENT DID NOT HAVE ANY CONCERNS WITH THE REMOVAL OF THE INFUSION SET ADHESIVE OR THE NEEDLE BOX. ALLEGED INFUSION SET WAS 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R INSULIN (DATE OF TX (B)(6))| INSULIN INFUSION DEVICE,| (DATE OF TX (B)(6))