BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 4210841 · Received October 29, 2014

    Report

    Report Number
    1823260-2014-08365
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    January 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    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.

    Description of Event or Problem · 1

    CALLER REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVEL FOR TWO WEEKS OF 14-16 MMOL/L DUE TO INCORRECT INSULIN DELIVERY. CALLER STATED THERE ARE DROPS OF INSULIN INSIDE OF THE PUMP. CALLER REPORTED THE PATIENT SWITCHED OFF THE PUMP AND DRIED IT BUT AFTER STARTING TO USE IS, CONDENSATION APPEARED AGAIN. CALLER STATED AFTER CHANGING TO A NEW PUMP, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS BETTER THE NEXT DAY WITH READINGS IN MORNING OF 4.4 MMOL/L AND LATER 5.2 MMOL/L. PATIENT WAS TREATED WITH INSULIN BY A LAYPERSON AND A MEDICAL PROFESSIONAL; WAS NOT HOSPITALIZED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694014 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32116123

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR Required Intervention