BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3220993 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01260
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 5, 2013
    Report Date
    October 7, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND CLICK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WIFE REPORTED AN INFUSION HEADSET LEAKED INSULIN DUE TO A BENT CANNULA. THIS WAS DISCOVERED WHEN THE INFUSION DEVICE DISPLAYED AN E4 OCCLUSION ERROR, AND THEY INSPECTED THE INFUSION SET AND FOUND THE ADHESIVE WAS WET. THE INFUSION DEVICE HAS DISPLAYED SEVERAL E4 ERRORS OVER THE LAST 3 DAYS. THE HEADSET IS INSERTED MANUALLY, AND THERE WAS AN AUDIBLE CLICK WHEN THE TUBE IS CONNECTED TO THE HEADSET. PATIENT'S INSERTION TECHNIQUE AND SITE ROTATION WERE REVIEWED, AND HE WAS SENT AN INSERTION DEVICE. WIFE REPORTED THE PATIENT IS "SHAKY" AND BELIEVES THE BENT CANNULAS ARE CAUSED BY HIS INSERTION TECHNIQUE. THE ALLEGED INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. FOLLOW-UP WAS COMPLETED ON (B)(6) 2013. THE HEADSET WAS CHANGED ON (B)(6) 2013 AND IS FUNCTIONING NORMALLY, AND HIS BLOOD GLUCOSE HAS BEEN "VERY GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320343 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 5019857

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR BUPROPINE| LISINOPRIL| VITAMIN B12| CALCACETATE| NOVOLOG U100 INSULIN| VITAMIN D3| SIMVASTATIN| CLONODINE| PRILOSEC OTC| HYDRALAZINE| LABETALOL| AMLODIPINE