BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1999683 · Received February 23, 2011

    Report

    Report Number
    2939301-2011-01600
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 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 K 053529. 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.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC HIGH READINGS ON HER SON'S ONE TOUCH ULTRA 2 METER. THE REPORTER MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2011. THE PATIENT OBTAINED A RESULT OF 175 MG/DL AND A 192 MG/DL GREATER THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT HAD TAKEN AN UNSPECIFIED AMOUNT OF INSULIN BASED ON THE METER READINGS AND AT AN UNSPECIFIED TIME LATER, THE PATIENT FELT SHAKY AND CLAMMY. THE PATIENT SELF-TREATED HERSELF WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED ERRATIC HIGH READINGS, THE PATIENT HAD TAKEN INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2608823

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening