BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2230133 · Received August 31, 2011

    Report

    Report Number
    2939301-2011-08443
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/08/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 2011 THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6), 2011 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.

    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 HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 1:30PM. SHE CLAIMED SHE TESTED HER BLOOD GLUCOSE ON THE SUBJECT METER AND RECEIVED A READING OF "524MG/DL" WHICH SHE FELT WAS HIGHER COMPARED TO HER NORMAL READINGS AND FEELINGS. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN AND IS A SELF-ADJUSTER. THE PATIENT CLAIMED THAT WHEN SHE GOT THE ALLEGED INACCURATE RESULT ON THE SUBJECT METER, SHE ADMINISTERED 4 UNITS OF NOVOLOG AT APPROXIMATELY 1:38PM. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS BUT SHE CLAIMED THAT HER HUSBAND CAME HOME AT APPROXIMATELY 2PM AND FOUND HER UNCONSCIOUS. THE PATIENT STATED HER HUSBAND CALLED THE PARAMEDICS AND WHEN THEY ARRIVED, THEY TESTED HER BLOOD GLUCOSE ON THEIR METER (UNKNOWN NAME) AT 2:30PM AND RECEIVED A READING OF 47MG/DL. THEY REPORTEDLY TREATED HER WITH IV GLUCOSE AND RETESTED HER BLOOD GLUCOSE ON THEIR DEVICE AND RECEIVED A 240MG/DL AT APPROXIMATELY 3:30PM BEFORE THEY LEFT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. HOWEVER, THE CONTROL SOLUTION TEST RESULT WAS NOT WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND WAS TREATED BY AN HCP 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. 3093946

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R