BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2110726 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04528
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS EXPECTED RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED ISSUE BEGAN. THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "119 AND 74 MG/DL" WITH THE SUBJECT METER. THE CCA WAS ADVISED THE PATIENT DOES NOT TAKE MEDICATION TO MANAGE HIS DIABETES AND CONTINUED TO FOLLOW HIS USUAL MANAGEMENT ROUTINE. AFTER THE ALLEGED ISSUE BEGUN, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF INCOHERENT, SHAKY, COLD SWEAT AND LETHARGIC. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. ON THE EVENING OF (B)(6) 2011, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "129 MG/DL" ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CCA WALKED THE PATIENT THROUGH CORRECTLY CODING THE SUBJECT METER TO MATCH THE TEST STRIPS. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3089982

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R