BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2183232 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06576
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED 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. 510K # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS ENTERING THE SETUP MODE INSTEAD OF THE TESTING MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE PATIENT HAD WITH THE CUSTOMER CARE ADVOCATE (CCA), SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SHE PURCHASED THE SUBJECT METER ON (B)(6) 2011 AND THE ALLEGED ISSUE BEGAN AS SOON AS SHE ATTEMPTED TO USE IT. IT IS NOT KNOWN IF THE PATIENT WAS ABLE TO TEST WITH THE SUBJECT METER BETWEEN WHEN SHE PURCHASED THE SUBJECT METER AND CONTACTED LFS. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN; HOWEVER, IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE DAY PRIOR TO PURCHASING THE SUBJECT METER, THE PATIENT CLAIMED SHE HAD JUST BEEN DISCHARGED FROM THE HOSPITAL AFTER BEING TREATED FOR HYPERGLYCEMIA. PRIOR TO BEING ADMITTED TO THE HOSPITAL, THE PATIENT CONFIRMED SHE WAS OBTAINING HIGH RESULTS WITH A DIFFERENT LFS DEVICE. HOWEVER, THE PATIENT CLAIMED AFTER THE ALLEGED ISSUE BEGAN AND AFTER BEING DISCHARGED FROM THE HOSPITAL (ON (B)(6) 2011), SHE WAS HOSPITALIZED AGAIN FOR THE SAME REASON. THE PATIENT DID NOT RECALL THE DATE SHE WAS DISCHARGED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY WAS HOSPITALIZED FOR A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R