BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2734058 · Received September 7, 2012

    Report

    Report Number
    2939301-2012-10296
    Event Type
    Injury
    Date Received
    September 7, 2012
    Report Date
    August 13, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON [(B)(4) 2012] WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR HER NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN ON 07/30/2012. THE PATIENT CLAIMED THAT SHE OBTAINED BLOOD GLUCOSE RESULTS OF ''153 197 214 278 170 169 190 127 169 162 AND 213 MG/DL'' WITH THE SUBJECT METER. THE PATIENT REPORTED MANAGING HER DIABETES WITH INSULIN (SELF ADJUSTING) AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT DUE TO THE ALLEGED ISSUE STARTING. THE PATIENT TOLD THE CCA THAT SHE DEVELOPED ''BLURRY VISION'' ON (B)(6) 2012. HOWEVER, THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE. DURING TROUBLESHOOTING THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE PATIENT WAS CORRECT/UNEXPIRED TEST STRIPS. DURING TROUBLESHOOTING THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A CONTROL TEST. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. HOWEVER, REPLACEMENT PRODUCT WAS STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3296421

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening