BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1930804 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10794
    Event Type
    Injury
    Date Received
    December 16, 2010
    Report Date
    November 20, 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. A 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 HAS A CRACKED DISPLAY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT ON (B)(6) 2010 AND (B)(6) 2010 FOR FOLLOW UP QUESTIONS; HOWEVER, THE PATIENT WAS NOT ABLE TO BE REACHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY IN (B)(6) 2010 PRIOR TO CONTACTING LFS. THE PATIENT STATED SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. IMMEDIATELY AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE WAS EXPERIENCING A SEIZURE. IN RESPONSE TO THE SYMPTOM, THE PATIENT REPORTED SHE WAS HOSPITALIZED AND WAS TREATED WITH IV GLUCOSE. AT THE TIME OF THE HOSPITALIZATION, THE PATIENT DENIED BEING TESTED ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE SUBJECT METER WAS MISUSED. THE PATIENT STATED THAT HER DOG KNOCKED THE METER INTO THE WATER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT KNOWN WHEN THE PATIENT LAST TESTED OR WHETHER SHE WAS ABLE TO OBTAIN A READING ON THE SUBJECT METER. THE MSS WAS NOT ABLE TO CONFIRM ON HOW SOON AFTER THE PATIENT DEVELOPED THE ALLEGED SYMPTOM. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R