BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3896258 · Received June 26, 2014

    Report

    Report Number
    1823260-2014-04697
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOKE UP WITH AN ELEVATED BLOOD GLUCOSE LEVEL OF AROUND 380 MG/DL. HE FOUND HIS INFUSION TUBING WAS BROKEN. HE CHANGED HIS INFUSION SET AND BLOUSED 8-10 UNITS OF INSULIN VIA INJECTION. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374524 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5040414

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR