BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1955429 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00320
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 6, 2010
    Report Date
    December 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 HIS ONETOUCH ULTRA2 METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 BETWEEN 6:00AM AND 9:00AM. THE PATIENT INDICATED HE MANAGES HIS DIABETES WITH COMBINATIONS OF ORAL MEDICATIONS SUCH AS GLYBURIDE 5MG AND METFORMIN 1000MG TWICE DAILY. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED HE CONTINUED TAKING HIS USUAL DOSE OF DIABETES MEDICATIONS. A WEEK AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE BECAME DIZZY AND WEAK. (B)(6) 2010 AT 10:00AM, THE PATIENT STATED HE WENT TO SEE HIS HEALTH CARE PROVIDER (HCP). ACCORDING TO THE PATIENT, HE WAS TREATED WITH INSULIN AT THE DOCTOR'S OFFICE VISIT, BUT HE COULD NOT RECALL THE TYPE AND DOSE THAT WAS GIVEN TO HIM. THE PATIENT REPORTED BEING TESTED BY THE DOCTOR/CLINIC METER AND OBTAINED A RESULT OF "320 MG/DL" AT THE TIME OF THE DOCTOR'S OFFICE VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE SUBJECT METER WAS MISUSED. THE CCA NOTED THE METER GOT WET IN THE PATIENT'S SUITCASE WITH A WATER BOTTLE ON HIS WAY TO WORK. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY REQUIRED HCP INTERVENTION 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. 2969652

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention