BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2801665 · Received October 23, 2012

    Report

    Report Number
    2939301-2012-12262
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 16, 2012
    Report Date
    October 1, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4) 2012) DEVICE EVALUATION: THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE 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

    (B)(4): THE METER WAS EVALUATED AND NO FAULTS WERE FOUND. THE PRIMARY COMPLAINT WAS RESOLVED BY CUSTOMER SERVICE DURING TROUBLESHOOTING.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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH ULTRA2 METER WAS READING THE CONTROL SOLUTION WAS READING INACCURATELY COMPARED TO ANOTHER CONTROL SOLUTION READING ON THE SAME METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 DURING THE DAY, THE PATIENT REPORTED OBTAINING CONTROL SOLUTION READINGS OF "150 AND 160MG/DL" ON THE LFS METER. THE PATIENT REPORTED USING NON ADJUSTING INSULIN (UNKNOWN TYPE AND DOSE) TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 AT 7PM, SHE HAD SOMETHING MORE TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED A FEW MINUTES AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF "SHAKINESS, DIZZINESS AND SWEATING." THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME, SHE "DRANK JUICE, LAID DOWN AND RESTED." THE PATIENT REPORTED TESTING ON ANOTHER DEVICE ON (B)(6) 2012 AT 7PM, BUT DID NOT RECALL THE RESULT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION AND IT WAS EXPIRED. THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT'S TESTING PROCESS WAS CORRECT. THE CCA CONFIRMED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. HOWEVER WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS NOT WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3235959

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R