BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2120327 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01559
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1486-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011 AT 10:30 PM, THE PT'S BLOOD GLUCOSE MEASURED 110 MG/DL BEFORE BED. ON (B)(6) 2011 AT 8 AM, HER BLOOD GLUCOSE WAS HIGH WHEN SHE WOKE UP AND SHE COLLAPSED BUT WAS NOT UNCONSCIOUS. HER MOTHER CALLED THE AMBULANCE AND THE PT WAS TRANSPORTED TO THE HOSP. HER BLOOD GLUCOSE MEASURED 980 MG/DL AT 8:30 AM. UPON F/U WITH THE PT'S FATHER, HE STATED THE PT'S DOCTOR FOUND THE CANNULA OF THE INFUSION SET WAS BENT. THE PT WAS RELEASED FROM THE HOSP ON (B)(6) 2011. NO FURTHER INFO IS AVAILABLE. THE INFUSION SET WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O| R INSULIN: (DATE OF TX (B)(6))| INSULIN INFUSION DEVICE:| (DATE OF TX (B)(6))