BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1902400 · Received November 18, 2010

    Report

    Report Number
    2939301-2010-10097
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 K061118.

    Description of Event or Problem · 1

    ON NOVEMBER 5, 2010, THE LAY USER/REPORTER IN (B)(6), THE PATIENT'S SON, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. SINCE APPROXIMATELY (B)(6) 2010, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. DUE TO THE METER ISSUE, THE PATIENT DID NOT TAKE HIS PRESCRIBED DOSES OF INSULIN. ON (B)(6) 2010, THE PATIENT ATE NO FOOD, AND DRANK WATER ONLY. AT 3:00 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF DRY MOUTH AND WEAKNESS. FAMILY MEMBERS CONTACTED THE PHYSICIAN, WHO ARRIVED AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 495 MG/DL. THE PATIENT WAS TREATED WITH TEN UNITS "FAST-ACTING" INSULIN, AND TWENTY UNITS "SLOW-ACTING" INSULIN. TROUBLESHOOTING REVEALED THE PATIENT HAD CORRECTLY REPLACED THE METER'S BATTERY, AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY BECAME HYPERGLYCEMIC AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R