BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2183136 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06575
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 ON (B)(6) 2011 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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER WAS DISPLAYING AN ERROR 2 ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT ON (B)(6) 2011 HE WAS UNABLE TO PERFORM A BLOOD GLUCOSE TEST DUE TO RECEIVING AN "ERROR 2" ERROR MESSAGE. PER THE ONE TOUCH ULTRA METER OWNER'S BOOKLET AN ERROR 2 MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES USING INSULIN (UNKNOWN TYPE AND DOSE) AND IS A SELF ADJUSTER. THE PATIENT DENIED MAKING ANY CHANGES TO HIS NORMAL DIABETES REGIMEN IN RESPONSE TO THE ALLEGED ERROR 2 MESSAGE. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "SHAKING AND SWEATING" AFTER THE ALLEGED ISSUE BETWEEN (B)(6) 2011 AND DENIED RECEIVING ANY MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THE PATIENT WAS ABLE TO SUCCESSFULLY RETEST OVER THE PHONE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3082792

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening