BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1801964 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06657
    Event Type
    Injury
    Date Received
    August 16, 2010
    Report Date
    July 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRAMINI METER WOULD NOT POWER ON. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON AN UNSPECIFIED DATE TOWARDS THE END OF (B)(6) AT AROUND 6:00-7:00 AM. THE PATIENT DENIED THAT SHE DEVELOPED ANY SYMPTOMS BECAUSE OF THE ALLEGED ISSUE. HOWEVER, DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE RECEIVED IV FLUID TREATMENT AND AN INSULIN DRIP FROM AN EMERGENCY ROOM (ER). THE PATIENT ALSO DENIED THAT HER BLOOD GLUCOSE WAS TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT HER LAST METER READING WAS BEFORE THE ALLEGED ISSUE BEGAN, WHAT DATE/TIME THE LAST METER READING WAS OBTAINED, AND WHAT DATE/TIME SHE RECEIVED THE IV TREATMENT. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE ER VISIT, AND IF THE ER TESTED THE PATIENT'S BLOOD GLUCOSE. THE PATIENT DID NOT HAVE TEST STRIPS FOR TROUBLESHOOTING. THE METER AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE RECEIVED IV FLUID AND INSULIN THERAPY FROM AN ER AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R