BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2565072 · Received May 8, 2012

    Report

    Report Number
    2939301-2012-04929
    Event Type
    Injury
    Date Received
    May 8, 2012
    Report Date
    April 30, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED ((B)(4) 2012) BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/31/2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE AND HER FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN AS SOON AS SHE BEGAN TO TEST WITH THE SUBJECT METER, WHICH THE PATIENT REPORTED WAS 3-4 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED OBTAINING ALLEGED INACCURATE HIGH READINGS OF "OVER 200, 191, 217, 161, 159, 185, 181 AND 201 MG/DL" WITH THE SUBJECT METER; HOWEVER, THE DATES AND TIMES OF THOSE RESULTS WERE NOT PROVIDED. THE PATIENT ALSO STATED THAT ON AN UNSPECIFIED DATE SHE OBTAINED BLOOD GLUCOSE READINGS OF "154 MG/DL" ON THE SUBJECT METER AND "122 MG/DL" ON ANOTHER DEVICE (CONTOUR METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED LFS'S CRITERIA FOR ACCURACY. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). SHE DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "SWEATY, WEAK AND MENTALLY CONFUSED" AT AN UNSPECIFIED TIME AFTER THE ALLEGED INACCURACY BEGAN. THE PATIENT REPORTED TREATING HERSELF WITH FOOD AND/OR DRINK ON EITHER (B)(6) 2012. AT THE TIME OF TROUBLESHOOTING THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE AS WELL AS CORRECT TESTING PROCESS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER OBTAINING ALLEGED INACCURATE HIGH READINGS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3261772

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R