BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 1845703 · Received September 27, 2010

    Report

    Report Number
    2939301-2010-08525
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 510K#: K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT SHE HAD RUN OUT OF ONE TOUCH ULTRA TEST STRIPS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 THE PATIENT NOTED SHE HAD NO MORE REPORTED TEST STRIPS; SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS. ONE WEEK LATER, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH INSULIN. TROUBLESHOOTING REVEALED THERE WAS NO MISSING PRODUCT OR MALFUNCTION. THE TEST STRIPS WERE REPLACED. THE PATIENT RAN OUT OF TEST STRIPS. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO NOT HAVING ANY TEST STRIPS, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    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 Life Threatening| R