BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2143379 · Received June 29, 2011

    Report

    Report Number
    2939301-2011-05345
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. 510K#: K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/08/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. A DHR (DEVICE HISTORY RECORD) WAS ALSO COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER /PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING THE ERROR 1 ERROR MESSAGE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. THE COMPLAINT HAS BEEN CLASSIFIED BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE "THREE MONTHS AGO", THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 1 ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. DURING THIS TIME PERIOD, THE PATIENT CONTINUED TO TAKE HER ORAL DIABETES MEDICATIONS. THE PATIENT NOTED SHE TESTED HER BLOOD GLUCOSE LEVELS ONLY ONCE/WEEK. TWO WEEKS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF "HYPOGLYCEMIA"; SPECIFIC SYMPTOMS NOT PROVIDED. THE PATIENT TOOK NO ACTIONS DUE TO HER SYMPTOMS AND DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S SPECIFIC SYMPTOMS, HER EXPECTED BLOOD GLUCOSE READINGS, HER DIABETES MEDICATION REGIMEN, AND IF THE PATIENT ATTEMPTED TO USE THE REPORTED METER BEFORE OR DURING THE HYPOGLYCEMIC EPISODE. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER ISSUES. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening