BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 1909371 · Received November 29, 2010

    Report

    Report Number
    2939301-2010-10327
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 24, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 K043197.

    Description of Event or Problem · 1

    ON NOVEMBER 24, 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE NOT DRAWING HER BLOOD SAMPLES IN. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010 AT 3:00AM. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT ROUTINE. THE PATIENT INDICATED SHE WAS NOT FEELING WELL AND COULD NOT GET OUT OF BED AFTER THE ALLEGE ISSUE BEGAN. ON THE SAME DAY AT AROUND 3:00AM, SINCE THE PATIENT WAS NOT ABLE TO TEST ON THE SUBJECT METER, SHE CONTACTED EMERGENCY MEDICAL SERVICE (EMS). THE PATIENT STATED SHE WAS TESTED BY THE EMS METER AND OBTAINED A READING OF "2.4 MMOL/L" AND WAS ADMINISTERED GLUCOSE TABLET/GLUCOSE GEL. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THAT THE PATIENT'S TESTING PROCEDURE WAS CORRECT. THE PATIENT WAS NOT ABLE TO PERFORM ANOTHER BLOOD TEST SINCE SHE DID NOT HAVE TEST STRIPS AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R