BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2220914 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07933
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE PATIENT RETURNED THE METER FOR INVESTIGATION. PRODUCT ANALYSIS WAS PERFORMED, AND THE METER PASSED TESTING. THE 510K # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY LOW READINGS WITH THE CONTROL SOLUTION. ON (B)(6) 2011, THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. THE SMSS MAILED A LETTER REQUESTING THE PATIENT CONTACT MEDICAL SURVEILLANCE. ON (B)(6) 2011, THE PATIENT OBTAINED THE CONTROL SOLUTION RESULTS OF 112 MG/DL AND 105 MG/DL ON THE REPORTED METER WHICH WERE OUT OF RANGE LOW FOR THE LOT OF TEST STRIPS IN USE. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT STATED SHE CONTACTED HER PHYSICIAN FOR ASSISTANCE/ADVICE, AND WAS ADVISED TO CONTACT LIFESCAN. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL AFTER THE CONTROL SOLUTION TESTS AND IF SO WHAT WAS THE READING, HER EXPECTED READINGS, THE DATE/TIME OF THE ONSET OF SYMPTOMS, AND IF THE PATIENT SOUGHT ANY MEDICAL ATTENTION OR TREATMENT FOR THE REPORTED SYMPTOMS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE OBTAINED OUT OF RANGE CONTROL SOLUTION RESULTS ON THE REPORTED METER. IT IS NOT CLEAR IF THERE WAS A DELAY IN TESTING OR TREATMENT DUE TO THE METER 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. 3120507

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening