BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1902409 · Received November 18, 2010

    Report

    Report Number
    2939301-2010-10096
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    November 2, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE HEALTHCARE PROFESSIONAL/REPORTER IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE REPORTER TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A BLOOD GLUCOSE READING ON THE REPORTED METER THAT WAS "50 MG/DL HIGHER" THAN A LABORATORY RESULT. NO SPECIFIC DATA WAS PROVIDED. AT THAT TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF "HYPOGLYCEMIA". IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE SPECIFIC RESULTS OBTAINED, THE PATIENT'S SPECIFIC SYMPTOMS OF HYPOGLYCEMIA, THE TIME OF ONSET OF SYMPTOMS, THE DATE AND TIME OF THIS EVENT, THE PATIENT'S BLOOD GLUCOSE READINGS AND MEDICATIONS TAKEN PRIOR TO THE EVENT, IF THE PATIENT RECEIVED ANY TREATMENT OR MEDICAL ATTENTION, THE PATIENT'S DIABETES MEDICATION REGIMEN, AND EXPECTED RESULTS. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN EXPIRATION DATING. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF HYPOGLYCEMIA WHILE USING THE REPORTED METER AND OBTAINING BLOOD GLUCOSE READINGS HIGHER THAN LABORATORY RESULTS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE THE DEVICE WOULD NOT SEAL PROPERLY, DID NOT WORK. THE JAWS WERE CLEANED WITH A DAMP SPONGE AND STILL DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3025314

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening