BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3840290 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03847
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 6, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    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

    CALLER REPORTED THE INFUSION SETS TO THE PUMP ARE LEAKING AT THE INFUSION SITE, WHERE THE HEADSET IS INSERTED INTO THE BODY. CALLER STATED THE ISSUE BEGAN ABOUT 2 MONTHS AGO. CALLER REPORTED SHE NOTICED THE LEAK WHEN HER BLOOD GLUCOSE LEVEL BECAME ELEVATED; EXACT READING WAS NOT PROVIDED. CALLER STATED TO TREAT THE ELEVATED BLOOD GLUCOSE LEVEL SHE CHANGED THE INFUSION SET; NO OUTSIDE ASSISTANCE WAS NEEDED. CALLER REPORTED ALL OF THE INFUSION SETS CAME FROM THE SAME BOX. CALLER DISCARDED THE ALLEGED INFUSION SETS. NO ADVERSE EVENT REPORTED. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318118 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 219241

    Patients

    Seq Age Sex Outcome Treatment
    1