BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SURESTEP METER

    MDR report key: 2034517 · Received March 31, 2011

    Report

    Report Number
    2939301-2011-02701
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 510(K) # IS K022724.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS 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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A TEST STRIP HOLDER/PORT ISSUE WITH HER ONETOUCH SURESTEP ORIGINAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 10:00AM. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH PILLS AND DIET/EXERCISE. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT. A DAY OR 2 AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT INDICATED SHE WAS FEELING THIRSTY. IN SPITE OF HER SYMPTOM, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THERE WAS NO MISUSED OF THE SUBJECT METER AND THE PATIENT WAS NOT A FIRST TIME USER OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOM SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening