BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1955361 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00312
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS DISPLAYING AN UNKNOWN/UNSPECIFIED ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AROUND LUNCH TIME ON (B)(6), 2010. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN (NOVOLIN 25 UNITS). ON (B)(6), 2010 AT 8:30AM, THE PATIENT INDICATED SHE ADMINISTERED HER USUAL DOSE OF INSULIN. THE PATIENT STATED SHE WAS FEELING A LITTLE SWEATY 4 HOURS AFTER THE ALLEGED ISSUE BEGAN. BASED ON THE SYMPTOM, THE PATIENT CLAIMED SHE SELF TREATED WITH FOOD AND/OR DRINK. AFTER EATING, THE PATIENT INDICATED SHE TESTED ON A CONTOUR BRAND METER AND OBTAINED A RESULT OF "110 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THIS WAS NOT THE FIRST TIME THE PATIENT HAD USED THE SUBJECT METER. THE CCA ASSISTED THE PATIENT IN RESOLVING THE ALLEGED UNKNOWN/UNSPECIFIED ERROR MESSAGE. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY BECAME HYPOGLYCEMIC AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068403

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R