BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2013578 · Received March 10, 2011

    Report

    Report Number
    2939301-2011-02048
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/11/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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 REPORTER CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS SON'S ONE TOUCH ULTRA EASY METER. REPORTER MENTIONED THAT ON (B)(6) 2011 THE PATIENT OBTAINED A 245MG/DL ON THE ULTRAEASY METER AND A 142 MG/DL ON ANOTHER OT METER. HE WAS GIVEN INSULIN AFTER OBTAINING THE ALLEGED HIGH READING OF 245 MG/DL ON HIS METER. APPROXIMATELY 10 MINUTES LATER, HE HAD DIFFICULTLY SEEING AND HIS MOTHER TREATED HIM WITH 2 SPOONS OF JAM. HE FELT BETTER SOON AFTER TREATMENT. THE PATIENT THEN TESTED ON A NEIGHBOR'S METER AND OBTAINED A 62 MG/DL AFTER TREATMENT. THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A CONTROL TEST AND THE TEST STRIPS PASSED USING THE CONTROL TEST; HOWEVER, IT WAS NOTED THAT THE TEST STRIPS EXPIRED ON (B)(6) 2011. PATIENT RAN OUT OF THE SUBJECT TEST STRIPS; THEREFORE UNABLE TO RETURN THE SUBJECT METER LOT. PRODUCT WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE HIGH READING, HAD TAKEN INSULIN BASED ON METER READING, DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, HAD TO BE TREATED WITH FOOD AND FELT BETTER AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2989811

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening| R