BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2192028 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06836
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 31, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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. 510K#: K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 5:30 PM THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. EIGHT HOURS LATER, THE PATIENT ALLEGEDLY SUFFERED THE SYMPTOM OF FREQUENT URINATION. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE METER'S BATTERY DID NOT NEED TO BE REPLACED AND THE TEST STRIPS WERE CORRECT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER POWER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3042121

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening