BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3991915 · Received August 8, 2014

    Report

    Report Number
    2939301-2014-20095
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 31, 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 CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH ULTRA2 METER HAD A LINE THROUGH THE DISPLAY. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN A WEEK AGO. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE, HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE PRODUCT ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, APPROXIMATELY THREE TO FOUR DAYS PRIOR TO CONTACTING LFS THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF DIZZINESS AND SWEATING AS A RESULT OF THE ALLEGED ISSUE; THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION AFTER THE REPORTED METER ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE PRODUCT FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE SUBJECT METER. A REPLACEMENT METER WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472144 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3500572

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening