BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2896205 · Received December 7, 2012

    Report

    Report Number
    2183996-2012-01946
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED AN INFUSION SET LEAKED INSULIN A FEW WEEKS AGO. SHE SMELLED INSULIN AND NOTICED A WET SPOT AROUND HER INFUSION SITE. SHE IMMEDIATELY CHANGED THE HEADSET. THE INFUSION SITE WAS ON HER STOMACH, AND THERE WAS NO SCAR TISSUE IN THE AREA. THE HEADSET WAS INSERTED WITH AN INSERTION DEVICE, AND THE CANNULA WAS NOT BENT WHEN IT WAS REMOVED. SHE DID HEAR AN AUDIBLE CLICK WHEN SHE CONNECTED THE HEADSET TO THE TUBE. THE ALLEGED PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. PATIENT WAS UNABLE TO DETERMINE THE CAUSE OF THE LEAK AND WAS SENT REPLACEMENT INFUSION SETS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 216115

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES| DATE OF THERAPY: UNK