BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1982078 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01220
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 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) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HIS TESTING FREQUENCY IS 4-6 TIMES DAILY AND MANAGES HIS DIABETES WITH ORAL MEDICATION OF METFORMIN. THE PATIENT INDICATED HE TAKES 1000 MG OF ORAL MEDICATION IN THE MORNING AND 500 MG AT NIGHT. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7:00AM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "144, 140 AND 128 MG/DL" WITH THE SUBJECT METER. ON THE ONSET OF THE ALLEGED ISSUE, THE PATIENT CONFIRMED HE WENT TO EXERCISE. THE PATIENT CONFIRMED ½ AN HOUR LATER HE WAS FEELING SHAKY, HUNGRY, SWEATY, AND "REAL ANXIOUS"; WHICH HE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO HIS SYMPTOMS, THE PATIENT CONFIRMED HE DRANK A GLASS OF ORANGE JUICE AND HE FELT BETTER 2 HOURS LATER. THE PATIENT DENIED BEING TEST ON ANOTHER BLOOD GLUCOSE DEVICE AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY; HOWEVER HE DID NOT HAVE HIS CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2857001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening