BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3790488 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03186
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 15, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON(B)(6) 2014, THE PATIENT REPORTED THAT HER INFUSION TUBING HAS BEEN BREAKING OFF WHERE THE TUBE MEETS THE LUER LOCK. SHE STATED THAT THIS MOSTLY HAPPENS WHEN SHE IS ASLEEP AND SHE WAKES UP WITH WETNESS OF INSULIN AND ELEVATED BLOOD GLUCOSE LEVELS FROM 240-300'S MG/DL. SHE HAS BEEN ABLE TO CORRECT THE ELEVATED BLOOD GLUCOSE LEVELS BY CHANGING THE INFUSION SET AND BOLUSING VIA THE INFUSION DEVICE. THE ISSUE HAS OCCURRED WITH INFUSION SETS FROM TWO SEPARATE BOXES, BUT BOTH FROM THE SAME LOT NUMBER. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SETS WERE REPLACED AND WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269159 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5025230

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR HUMALOG