BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2222839 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08092
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LAY USER/PATIENT'S FIANCÉ CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 WAS GIVING AN UNKNOWN ERROR MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE REPORTER STATED THE ALLEGED ISSUE BEGAN IN (B)(6) 2011. THE REPORTER COULD NOT RECALL THE EXACT ERROR MESSAGE OR THE SPECIFIC DATE/TIME WHEN THE ISSUE OCCURRED. THE REPORTER INFORMED THE MSS THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSE). THE REPORTER CLAIMED THAT WHEN THE PATIENT WAS UNABLE TO CHECK HIS BLOOD GLUCOSE ON THE SUBJECT METER HE CONTINUED TO TAKE HIS INSULIN AS NORMAL. THE REPORTER CLAIMED THAT "A FEW WEEKS LATER" THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS OF "FREQUENT URINATION." THE REPORTER FURTHER STATED THAT THE PATIENT INCREASED HIS ACTIVITY LEVELS (EXERCISE) DUE TO HIS SYMPTOMS BUT COULD NOT RECALL IF THE SYMPTOMS SUBSIDED. THE REPORTER COULD NOT RECALL SPECIFIC DETAILS REGARDING THE REPORTED EVENT AND STATED THAT THE PATIENT HAD ALSO LOST THE CAP TO HIS LANCING DEVICE AND THEREFORE WAS NOT TESTING HIS BLOOD GLUCOSE FOR SOME TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE BATTERY HAD BEEN REMOVED FROM THE SUBJECT DEVICE AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THEREFORE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THAT THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R