BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1792180 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06439
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    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 TESTING WITH NO FAULTS FOUND. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A PAINFUL KNEE.

    Description of Event or Problem · 1

    ON JULY 27, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WAS GIVING THE ERROR 1 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 9:00 AM, THE PATIENT OBTAINED THE ERROR 1 ERROR MESSAGE ON THE REPORTED METER; HE DID NOT OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THE METER ISSUE. ON (B)(6) 2010 AT 11:00 AM, THE PATIENT EXPERIENCED THE SYMPTOMS OF DIZZINESS, SWEATING AND WEAKNESS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED USING ANOTHER METER, WITH THE RESULT OF 59 MG/DL. THE PATIENT RECEIVED TREATMENT WITH FOOD AND/OR A DRINK. HE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HIS DIABETES WITH SET DOSES OF INSULIN. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE REPORTED METER ISSUE, AND HE RECEIVED TREATMENT WITH FOOD. 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. 2637677

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R