BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2032958 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02684
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011 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 APPROXIMATELY ON THE AFTERNOON OF (B)(6) 2011. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN) AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED HE CONTINUED TO ADMINISTER HIS DOSE OF METFORMIN PILLS TWICE DAILY. THE PATIENT REPORTEDLY WAS EXPERIENCING HIGH BLOOD PRESSURE AND HAD SYMPTOMS OF SWEATING 15 DAYS AFTER THE ALLEGED ISSUE BEGAN. DUE TO THE REPORTED SYMPTOMS, THE PATIENT INDICATED HE MADE AN APPOINTMENT TO SEE HIS HEALTH CARE PROVIDER (HCP) ON (B)(6) 2011 AT 1:30 PM. AT THE TIME OF THE DOCTOR'S OFFICE VISIT, THE PATIENT STATED HE WAS ADVISED TO CONTINUED TAKING HIS ORAL MEDICATIONS AS USUAL AND TO CONTACT LFS BACK FOR ASSISTANCE ON THE SUBJECT METER. THE PATIENT DENIED BEING TESTED ON ANOTHER BLOOD GLUCOSE DEVICE AT THE TIME OF THE DOCTOR'S OFFICE VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NO MISUSED, THE BATTERIES NEEDED NO REPLACEMENT, AND THE CORRECT TEST STRIPS WERE USED; HOWEVER THE ALLEGED POWER ISSUE WAS NOT RESOLVED WITH TRAINING. 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 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3051078

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening