BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1936382 · Received December 22, 2010

    Report

    Report Number
    2939301-2010-10917
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    December 6, 2010
    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. A 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING THE ERROR 2 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE ERROR 2 ERROR MESSAGE ON THE REPORTED METER; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AFTERWARDS, THE PATIENT CLAIMED HE EXPERIENCED "HIGH BLOOD SUGAR" SYMPTOMS; HE DID NOT SPECIFY WHAT SYMPTOMS OCCURRED. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THERE WAS NO MISUSE OF THE PRODUCT, THE METER WAS NOT NEW, AND THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF HYPERGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE REPORTED METER ISSUE. 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. 2701137

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening