BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 4132547 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07494
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 7, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. PRODUCT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER WAS HOSPITALIZED WITH HYPERGLYCEMIA AND KETONES IN THE BLOOD. SHE WOKE IN THE MORNING AND FELT NAUSEOUS AND VOMITED, AND HER BLOOD GLUCOSE WAS 22.5 MMOL/L. SHE WAS TRANSPORTED TO THE HOSPITAL, WHERE SHE WAS ADMITTED AND TREATED WITH AN INTRAVENOUS DRIP. SHE WAS RELEASED LATER THAT DAY WITH A BLOOD GLUCOSE LEVEL OF 13.0 MMOL/L. THERE WAS A LARGE AIR BUBBLE IN THE CARTRIDGE, AND THE CUSTOMER COULD NOT SAY HOW OLD THE ADAPTER WAS. THE CUSTOMER WAS ADVISED ON PRODUCT RECOMMENDATIONS. FOLLOW-UP WAS COMPLETED WITH THE CUSTOMER. SHE CHANGED THE ADAPTER AND OTHER ACCESSORIES, AND THE INFUSION DEVICE NOW FUNCTIONS AS INTENDED. NO PRODUCT IS AVAILABLE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611342 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR Hospitalization| R NOT CURRENTLY ON ANY OTHER MEDICATIONS