BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2279449 · Received October 6, 2011

    Report

    Report Number
    2939301-2011-09857
    Event Type
    Injury
    Date Received
    October 6, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT TEST STRIPS WERE MISSING FROM THE ONETOUCH ULTRA TEST STRIP PACKAGING. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 1PM. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSE) AND DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT ROUTINE WHEN THE ALLEGED ISSUE OCCURRED. THE PATIENT CLAIMED THAT APPROXIMATELY 30 MINUTES LATER SHE DEVELOPED SYMPTOMS OF "THIRST, WAS SHAKY, FEELING REALLY BAD AND A HEADACHE." THE PATIENT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CONTENT OF THE PACKAGING WAS REVIEWED AND THE TEST STRIPS WERE FOUND TO BE MISSING. 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. 3065332

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening