BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2376940 · Received December 15, 2011

    Report

    Report Number
    2939301-2011-12335
    Event Type
    Injury
    Date Received
    December 15, 2011
    Report Date
    December 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (01/19/2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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) 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN INACCURATE ERRATIC ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED DAY "ONE MONTH AGO" PRIOR TO CONTACTING LFS. SHE OBTAINED GLUCOSE RESULTS OF "118, 117, 142, 144 AND 135 MG/DL" ON THE SUBJECT METER, DONE MORE THAN 20 MINUTES APART OF EACH OTHER. THE PATIENT DENIED TAKING ANY MEDICATIONS TO MANAGE HER DIABETES AND DUE TO THE ALLEGED ISSUE IT'S UNCLEAR IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. SHE CLAIMED "A FEW DAYS AGO" PRIOR TO CONTACTING LFS, SHE FELT "SHAKY AND LIGHTHEADED". IT IS UNKNOWN WHAT KIND OF GLUCOSE RESULTS SHE WAS OBTAINING AT THIS TIME. IN RESPONSE TO HER SYMPTOMS, ON (B)(6) 2011 SHE REPORTEDLY SELF TREATED WITH FOOD AND/OR DRINK. THERE WAS NOT ANOTHER DEVICE AVAILABLE AT THE TIME OF THE CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER AND AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3151912

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R