BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 4190388 · Received October 21, 2014

    Report

    Report Number
    1823260-2014-08101
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 13, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. (B)(6) LAW DOESN'T ALLOW PRODUCT RETURN.

    Description of Event or Problem · 1

    ON (B)(6) THE MORNING, BLOOD GLUCOSE WAS 16 MMOL/L AND THE PATIENT CHANGED THE NEEDLE. HE STATED THAT WHEN HE CHANGED THE TRANSFER SET, THE NEEDLE WAS BENT BUT PUMP DIDN'T SHOW AN E4, OR OCCLUSION ALERT. THE ADHESIVE OF THE INFUSION SET HEADSET WAS WET IN ADDITION TO THE CANNULA BEING BENT. AFTER THE BOLUS FOR THE CORRECTION THROUGH THE PUMP, THERE WAS NO EFFECT. THE PATIENT DIDN'T CHANGE THE INFUSION SET AND DIDN'T MAKE THE INJECTIONS OF INSULIN FROM PENS. THE NEXT MORNING, PATIENT'S BLOOD GLUCOSE WAS 40 MMOL/L AND HE WAS HOSPITALIZED FOR 4 DAYS. THE INFUSION DEVICE CANNOT BE RETURNED FOR LEGAL AND CUSTOMS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667676 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR Hospitalization UNSPECIFIED INSULIN