BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3831439 · Received May 25, 2014

    Report

    Report Number
    2939301-2014-12437
    Event Type
    Injury
    Date Received
    May 25, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 21, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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¿S RELATIVE CONTACTED LIFESCAN (LFS) CANADA ALLEGING THE PATIENT WAS OBTAINING AN UNKNOWN ERROR MESSAGE ON HIS ONETOUCH ULTRA2 METER. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER INFORMED THE CSR THAT THE ERROR MESSAGE APPEARED ON (B)(6) 2014. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF ORAL MEDICATION, DIET AND/OR EXERCISE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ERROR MESSAGE APPEARING. THE REPORTER CLAIMED THAT THE PATIENT FELT ¿SHAKY¿ 10 MINUTES AFTER THE ERROR MESSAGE APPEARED AND TREATED HIMSELF WITH GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED METER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER ATTEMPTING TO TEST WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309716 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3541582

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R