BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2061648 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03161
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PHARMACIST CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER DISPLAYS THE APPLY SAMPLE INDICATOR. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 10AM. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE REPORTER STATED THE PATIENT ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. IT IS NOT KNOWN IF THE PATIENT WAS TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE PRIOR TO THE START OF THE ALLEGED ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, 15 MINUTES AFTER THE ALLEGED ISSUE BEGAN THE PATIENT CONSUMED FOOD AND/OR DRINK. THE PATIENT REPORTEDLY TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AT 10:25AM; HOWEVER, THE RESULT IS NOT KNOWN. THIRTY MINUTES AFTER THE ALLEGED ISSUE BEGAN THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF SHAKING. HOWEVER, IT IS NOT KNOWN, WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED AFTER THE ALLEGED ISSUE BEGAN; IF TREATMENT WAS PROVIDED, IT IS NOT KNOWN WHO ADMINISTERED THE TREATMENT; AND IT IS ALSO NOT KNOWN HOW SOON AFTER THE PATIENT'S SYMPTOM IMPROVED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE (PER OWNER'S BOOKLET RECOMMENDATION) AND THE CORRECT TEST STRIPS WITH THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening