BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1916237 · Received December 7, 2010

    Report

    Report Number
    2939301-2010-10600
    Event Type
    Injury
    Date Received
    December 7, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING AN "APPLY SAMPLE" MESSAGE ON THEIR ONE TOUCH MINI METER. THE PATIENT MENTIONED THAT A WEEK PRIOR TO CONTACTING LFS, THE PATIENT OBTAINED AN "APPLY SAMPLE" ON THEIR ONE TOUCH MINI METER. LAST WEEK, THE PATIENT MENTIONED THAT SHE DEVELOPED SYMPTOMS OF SHAKING, NAUSEA, SWEATING AND BLURRED VISION. THE PATIENT SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE ALLEGED ISSUE WAS NOT RESOLVED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE APPLY SAMPLE MESSAGE, SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3059758

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R