BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2082350 · Received May 9, 2011

    Report

    Report Number
    2939301-2011-03811
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K021819. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. ON (B)(6) 2011 THE METER WAS FOUND TO HAVE SPC PINS LIFTED HIGH. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. ON (B)(6) 2011, THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS WERE ALSO TESTED AND THEY 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRASMART METER READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2011 AT APPROXIMATELY 8:00PM SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER (READING NOT PROVIDED) AND ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN BASED ON THE METER RESULT. THE PATIENT CLAIMED SHE WAS FEELING "HYPER" AT THE TIME OF THE TEST. SOMETIME AFTER TESTING, THE PATIENT REPORTED THAT SHE FELT NAUSEOUS AND THIRSTY. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE WENT TO THE HOSPITAL AND WAS TREATED WITH IV FLUIDS FOR A HIGH BLOOD GLUCOSE. THE PATIENT STATED THAT AT THE TIME OF THE HOSPITAL VISIT, SHE DID A COMPARISON TEST AND OBTAINED BLOOD GLUCOSE READINGS OF "16 MMOL/L" WITH THE SUBJECT METER AND "22 MMOL/L" ON A LABORATORY DEVICE, PERFORMED LESS THAN 10 MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE TWO GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20%. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE LOW READING(S) ON THE SUBJECT METER, TOOK A DECREASED DOSE OF INSULIN BASED ON THE ALLEGED RESULT(S), AND REPORTEDLY WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3071419

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L| R