BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2090196 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01306
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DIABETIC KETOACIDOSIS DUE TO INSULIN LEAKAGE FROM THE CONNECTION OF THE INFUSION SET TO THE INFUSION DEVICE. PATIENT WAS HOSPITALIZED ON (B)(6) 2011, AND WAS DISCHARGED ON (B)(6) 2011. PATIENT DID NOT SMELL OR FEEL THE INSULIN LEAKAGE. PATIENT CHANGED THE INFUSION SET, CARTRIDGE, AND ADAPTER AND RESUMED NORMAL OPERATION. PATIENT REPORTED HE WAS NOT CHECKING HIS BLOOD GLUCOSE FREQUENTLY; THEREFORE, HE DID NOT CATCH THE HIGH BLOOD GLUCOSE READINGS. ALLEGED PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

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