BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1841801 · Received September 22, 2010

    Report

    Report Number
    2939301-2010-08296
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    August 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH NOT PROVIDED.THE 510 (K) # IS K053529.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF HIS WIFE (THE PATIENT) ALLEGING AN APPLY SAMPLE ISSUE WITH A ONE TOUCH ULTRA 2 METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE REPORTER ON SEPTEMBER 22, 2010, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS. THE REPORTER WAS UNABLE TO PROVIDE A DATE/TIME AS TO WHEN THE ALLEGED ISSUE BEGAN. DUE TO THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR 6-7 DAYS. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF SWEATING AND TIREDNESS. HE COULD NOT RECALL WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED AS A RESULT OF DEVELOPING THE SYMPTOMS. ALSO, DUE TO THE ALLEGED ISSUE REPORTER CLAIMED THAT THE PATIENT HAD A DOCTOR¿S OFFICE VISIT ON (B)(6) 2010, AT 11:00 AM. HER BLOOD GLUCOSE WAS REPORTEDLY TESTED BY A LAB BUT THE REPORTER COULD NOT RECALL WHAT RESULT WAS OBTAINED. THE REPORTER MENTIONED THAT THE PATIENT WAS GIVEN A NEW PRESCRIPTION FROM HER DOCTOR BUT HE DID NOT KNOW THE DETAILS OF WHAT WAS PRESCRIBED. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE LAY USER/PATIENT'S PRODUCTS HAVE 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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED A SYMPTOM OF SWEATING WHICH CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRASMART METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6), 2010 THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 182 MG/DL AND 175 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. THE PATIENT TOOK NO ACTIONS BASED ON THESE READINGS. A FEW MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE OBTAINED ELEVATED READINGS ON THE REPORTED METER. 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. 2919386

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening