BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1960635 · Received January 13, 2011

    Report

    Report Number
    2939301-2011-00480
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    January 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HER EXPECTED RESULT. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HER BLOOD GLUCOSE 6X A DAY. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND LANTUS INSULIN (52 UNITS IN THE EVENING). IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "OVER 300 MG/DL" WITH THE SUBJECT METER. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT TOOK 20 UNITS HUMALOG INSULIN. AS A RESULT OF THE ACTION TAKEN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF BLURRY VISION, NAUSEA AND SWEATY. THE PATIENT ATE 20 JELLY BEANS AS TREATMENT AND FELT BETTER ABOUT 1-2 HOURS AFTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R