BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1893508 · Received November 8, 2010

    Report

    Report Number
    2939301-2010-09703
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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.

    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) 2010, THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. IN APPROXIMATELY (B)(4) 2010, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON AFTER IT HAD BEEN IMMERSED IN WATER IN THE CLOTHES WASHER. THE OWNER'S BOOKLET FOR THIS METER WARNS THE USER TO NOT ALLOW ANY LIQUIDS INTO THE METER'S TEST STRIP OR DATA PORTS. "A FEW HOURS" AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING, IMPAIRED VISION, HEADACHE AND IRRITABILITY. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND/OR A DRINK; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE METER AND TEST STRIPS WERE REPLACED. THERE WAS MISUSE OF THE PRODUCT BY ALLOWING WATER INTRUSION INTO THE METER. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE THOSE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2791943

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R