BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2170668 · Received July 21, 2011

    Report

    Report Number
    2939301-2011-06071
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    June 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH ULTRAEASY METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING IN CONTACT WITH THE PATIENT TO OBTAIN FOLLOW UP QUESTIONS AND TO REQUEST THE PRODUCT BACK FOR INVESTIGATION. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT ON (B)(6) 2011. THE PATIENT MENTIONED THAT HE HAD DONE BACK TO BACK READINGS AND HAD OBTAINED THE FOLLOWING READINGS:140, 155, 180 MG/DL. ON A DIFFERENT DAY HE TESTED AND OBTAINED A RESULT OF 140 MG/L AND THEN STARTED "TREMBLING" AND RETESTED 10 MINUTES LATER AND OBTAINED A RESULT OF 85 MG/D L. HE FELT THAT THE RESULT OF 85 MG/DL, REPRESENTED ON HOW HE WAS FEELING. THERE IS NO INFORMATION ON WHETHER THE PATIENT HAD SELF-TREATED. HE HAD VISITED HIS PHYSICIAN; HOWEVER, THERE IS NO INFORMATION ON WHETHER THE PATIENT RECEIVED ANY MEDICAL TREATMENT AT THE PHYSICIAN'S OFFICE OR WHETHER HE WAS TESTED ON THE PHYSICIAN'S METER. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, HOW LONG SYMPTOMS LASTED, WHETHER THE PATIENT SELF-TREATED PRIOR TO VISITING THE PHYSICIAN'S OFFICE AND INFORMATION OF WHAT HAPPENED AT THE DOCTOR'S OFFICE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT HE HAD OBTAINED ERRATIC READINGS AND WHEN HE TESTED HE HAD OBTAINED A HIGH READING OF 140 MG/DL, DEVELOPED SYMPTOMS, RETESTED AND OBTAINED A LOWER READING OF 85 MG/DL AND VISITED THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT HE HAD OBTAINED ERRATIC READINGS AND WHEN HE TESTED HE HAD OBTAINED A HIGH READING OF 140 MG/DL, DEVELOPED SYMPTOMS, RETESTED AND OBTAINED A LOWER READING OF 85 MG/DL AND VISITED HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2998704

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening