BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3242483 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01359
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    April 19, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREE USED RETURNED SAMPLE EXHIBITS A SINGLE BEND OF THE CANNULA. SAMPLES WERE TESTED FOR FLOW AND TIGHTNESS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    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) 2013, THE PATIENT REPORTED THAT SHE HAD BEEN IN THE HOSPITAL ON (B)(6) 2013 WITH ELEVATED BLOOD GLUCOSE IN THE 500'S MG/DL AND THE FLU. HER TARGET RANGE IS 80-120 MG/DL. SHE WAS TREATED WITH TWO INJECTIONS OF INSULIN AND AN IV OF SALINE SOLUTION. SHE STATED THAT THE DOCTOR REMOVED HER INFUSION SET AND SAW THAT THE CANNULA WAS BENT. THE PATIENT STATED THAT SHE THINKS THAT WAS THE CAUSE OF HER ELEVATED BLOOD GLUCOSE LEVEL. SHE CHANGED HER INFUSION SET AND HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. SHE STATED THAT SHE HAS HAD SEVERAL INFUSION SETS WITH BENT CANNULAS. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342918 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 5016691

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR Hospitalization| R HUMALOG U 100