BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2066360 · Received April 21, 2011

    Report

    Report Number
    2939301-2011-03307
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/26/2011)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011. EVALUATION WAS NOT ABLE TO CONFIRM THE ALLEGED ISSUES AND PASSED TESTING WITH NO FAULTS FOUND. RETAIN TEST STRIPS WERE ALSO TESTED ON (B)(6), 2011 AND PASSED TESTING WITH NO FAULTS FOUND. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED

    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 K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE NOT REGISTERING IN THE ONETOUCH ULTRAMINI 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 7:00AM. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES REGIMEN AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTEDLY WAS FEELING CHILLY, SWEATY, AND WAS "SLOW IN RESPONSE TO TIME". IN RESPONSE TO HER SYMPTOMS, THE PATIENT INDICATED SHE SELF-TREATED WITH FOOD AND/OR DRINK AT 8:30AM THAT DAY. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT STATED NO OTHER BLOOD GLUCOSE DEVICE WAS USED. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO RESOLVE THE ALLEGED ISSUE WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY BECAME HYPOGLYCEMIC AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3051908

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R