BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 4100574 · Received September 19, 2014

    Report

    Report Number
    2939301-2014-24806
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR OT MINI LANCING DEVICE HAD A DAMAGED LANCET HOLDER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE REPRESENTATIVE (CCR) DOCUMENTATION. THE PATIENT REPORTED THE ISSUE BEGAN ON (B)(6) 2014 AT 12.00PM THE LANCET HOLDER OF THE DEVICE BROKE AND THE PATIENT WAS UNABLE TO MAKE FREQUENT BLOOD GLUCOSE TESTS. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER). THE PATIENT CONFIRMED THAT HE DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT. THE PATIENT CLAIMS HE DEVELOPED SYMPTOMS OF ¿BLURRED VISION AND NOT FEELING WELL¿ 5 DAYS AFTER THE PRODUCT ISSUE BEGAN. THE PATIENT REPORTED VISITING DOCTOR¿S OFFICE ON SEPTEMBER 04, 2014, FOR A ROUTINE CHECK ¿UP, DURING THE VISIT THE PATIENT REPORTED HE DISCUSSED HIS SYMPTOMS. AS A RESULT OF THIS CONVERSATION, HIS DOCTOR PERFORMED A BLOOD GLUCOSE TEST; THE TEST RESULT WAS 47 G/DL. THE PATIENT ALLEGES BEING TREATED BY THE NURSE WITH FOOD AND DRINK (ORANGE JUICE AND JAM). THE PATIENT ALLEGES 30 MINUTES AFTER TREATMENT HE WAS FEELING BETTER AND WENT HOME. AT THE TIME OF TROUBLE SHOOTING, THE CCR CONFIRMED THIS WAS NOT THE FIRST TIME THE PRODUCT WAS IN USE, AND THE PRODUCT HAD BEEN IN USE FOR 1.5 YEARS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED WITH FOOD AND DRINK FOR A SERIOUS INJURY BY A HEALTH CARE PROVIDER AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581534 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R