BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1890422 · Received November 3, 2010

    Report

    Report Number
    2939301-2010-09671
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN 2 LIFTED HIGH. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. CORRECTION: (B)(6) 2010: THE LAY USER/PATIENT'S TEST STRIPS WERE RETURNED AND EVALUATED ON (B)(6) 2010 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS WERE ALSO TESTED AND PASSED ALL TESTING. THIS NARRATIVE WAS ERRANTLY OMITTED IN SUPPLEMENTAL #1 DATED (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109.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.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE DEVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE ARTERIAL BLOOD PARAMETER PROBE FAILED THE MANUFACTURING STANDARD REFERENCE SENSOR TEST. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4 ON (B)(6), 2010 ALLEGING AN ERROR 4 MESSAGE ON THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE FOLLOWING INFORMATION IS BASED ON THE INITIAL CALL THAT WAS PLACED ON (B)(6), 2010. THE PATIENT MENTIONED THAT ON (B)(6), 2010 AT 7:00PM, SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE AND WAS UNSUCCESSFUL IN OBTAINING A READING AND OBTAINED AN ERROR 4 MESSAGE. THE PATIENT DID NOT TAKE ANY ACTION AFTER OBTAINING THE ERROR 4 MESSAGE. AT 3:00AM, THE FOLLOWING MORNING SHE DEVELOPED "HYPOGLYCEMIA SYMPTOMS" AND WAS "MOVING AND SCREAMS ROUND". THE PATIENT WAS NOT TESTED ON ANOTHER METER AND WAS TREATED. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE TEST STRIPS ARE NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH TESTING AND THE REPORTED ISSUE WAS NOT RESOLVED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE EVENT, AND EXACT SYMPTOMS OF "HYPOGLYCEMIA", HOW LONG SYMPTOMS LASTED AND READINGS PRIOR TO THE REPORTED ISSUE. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERROR 4 MESSAGE, SHE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026718

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening