BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3072166 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08693
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER AND TEST STRIPS HAVE BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAVE NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING (B)(6) 2012 BETWEEN 1-3PM. THE PATIENT REPORTED OBTAINING READINGS OF "175MG/DL" ON THE LFS METER COMPARED TO "161MG/DL" ON A ONETOUCH ULTRAMINI METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=30% OR <=30MG/DL. THE PATIENT REPORTED BETWEEN (B)(6) 2012 TO (B)(6) 2013, HE INCREASED HIS DOSE OF "TENUBIA 100MG" TO ONE EXTRA PILL. THE PATIENT REPORTED SEVERAL DAYS TO WEEKS HE DEVELOPED SYMPTOMS OF "JITTERY AND NAUSEA." IT IS UNCLEAR IF THE PATIENT RECEIVED ANY TREATMENT IN RESPONSE TO HIS SYMPTOMS. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174684 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3419196

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R