BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 2855275 · Received December 4, 2012

    Report

    Report Number
    3008382007-2012-07049
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 15, 2012
    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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4) 2012) DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS, THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATE RESULTS COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 3AM, THE PATIENT REPORTED TESTING ON HER LFS DEVICE, AND OBTAINED BLOOD GLUCOSE VALUES OF "233, 258, 230 AND 201MG/DL," IN LESS THAN 20 MINUTES FROM EACH OTHER. THE PATIENT REPORTED TAKING NO MEDICATIONS TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 AT 3AM SHE HAD SOMETHING MORE TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED A COUPLE OF HOURS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTED FEELING "EXTREMELY SHAKY AND LIGHTHEADED." AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE CCA NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER AND TEST STRIPS INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS, THE COMPLAINT WAS NOT CONFIRMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED DUE TO THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3352192

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening