BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3863550 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04194
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 17, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THE INFUSION SET TO THE PUMP WAS LEAKY. MOTHER STATED THE ISSUE WAS DISCOVERED ON (B)(6) 2014. MOTHER REPORTED THE LEAK ORIGINATED FROM THE BODY SITE. MOTHER STATED THE PATIENT DISCOVERED THE LEAK WHEN HE CHECKED HIS BLOOD GLUCOSE AND IT WAS ELEVATED IN THE 500'S MG/DL. MOTHER REPORTED THIS IS WHEN THE PATIENT CHECKED THE INFUSION HEAD SET AND THE LEAKAGE OF INSULIN WAS DISCOVERED. MOTHER STATED THE PATIENT WAS ABLE TO GET THE BLOOD GLUCOSE LEVEL BACK DOWN TO TARGET RANGE WITH A COUPLE OF CORRECTION BOLUSES AND A NEW INFUSION SET WAS PUT ON; NO OUTSIDE ASSISTANCE WAS NEEDED. PATIENT DISCARDED THE ALLEGED INFUSION SET. NO ADVERSE EVENT REPORTED. REPLACEMENT WAS SENT; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337769 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5046633

    Patients

    Seq Age Sex Outcome Treatment
    1