BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2060325 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03134
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011. EVALUATION CONFIRMED THAT AN ERROR 5 OCCURRED WHEN TESTING WITH CONTROL SOLUTION. INVESTIGATION DISCOVERED THAT THE SPC PIN 2 WAS DIRTY AND SLIGHTLY LIFTED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. 510(K) # 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 DISPLAYING THE "ERROR 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 1:55PM. THE PATIENT INDICATED SHE IS ON INSULIN TO MANAGE HER DIABETES. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE CONTINUED TO ADMINISTER 10 UNITS OF HUMALOG INSULIN AS USUAL. 45 MINUTES LATER, THE PATIENT REPORTED FEELING SHAKY. THE PATIENT HOWEVER DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE, THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE TEST STRIPS WERE IN GOOD CONDITION, AND THE TEST STRIP DREW IN THE BLOOD SAMPLE; HOWEVER THE ALLEGED ERROR MESSAGE WAS NOT RESOLVED THROUGH A BLOOD RETEST. 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 DEVELOPED 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. 3105192

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening