BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2853142 · Received November 30, 2012

    Report

    Report Number
    3008382007-2012-06969
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 6, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 RESPECTIVELY 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 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 ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 BETWEEN 3:30-4PM PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED SHE WAS "UNCONSCIOUS." THE PATIENT REPORTED THE ALLEGED ISSUE STARTED "A WEEK AND A HALF" PRIOR TO CONTACTING LFS. ON AN UNKNOWN DATE AND TIME THE PATIENT ALLEGED OBTAINING A READING OF "100MG/DL." THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON (B)(6) 2012 BETWEEN 3:30-4PM A READING OF "28MG/DL" WAS OBTAINED AND SHE WAS TREATED BY EMS WITH IV GLUCOSE. IT IS UNCLEAR IF THE PATIENT REVIVED ON HER OWN, OR IF A THIRD PARTY FOUND HER AND CONTACTED EMS FOR TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT, AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. THE CCA NOTED THE PATIENT'S TESTING PROCESS WAS CORRECT, AND THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER AND TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS ON (B)(4) 2012 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED.THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3330263

    Patients

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