BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2063466 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03219
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNKNOWN ISSUE WITH HER ONETOUCH ULTRASMART METER WHICH PREVENTED HER FROM TESTING HER BLOOD GLUCOSE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND LANTUS INSULIN (22 UNITS IN THE MORNING). THE ALLEGED ISSUE BEGAN A FEW DAYS PRIOR TO CONTACTING LFS. THE PATIENT STATED SHE CONTINUED TO TAKE HER LANTUS INSULIN BUT DISCONTINUED TAKING HER HUMALOG INSULIN. ON THE FOLLOWING DAY OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT HIGH BLOOD GLUCOSE SYMPTOMS OF SWEATING, NERVOUS AND DIZZY. THE PATIENT WENT TO HER THE PHARMACY AND OBTAINED A BLOOD GLUCOSE RESULT OF "338 MG/DL" ON ANOTHER DEVICE. THE PATIENT ADMINISTERED SELF 4 UNITS HUMALOG INSULIN AND FELT BETTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) WAS NOT ABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. THE MSS WAS UNABLE TO HAVE THE PATIENT CLARIFY THE ALLEGED ISSUE. 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 HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3105189

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R