BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1882093 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09433
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS 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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K061118.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.

    Description of Event or Problem · 1

    CONSUMER STATED AS SHE REMOVED A TAMPON, THE TAMPON CAME APART AND SOME REMAINED INSIDE HER BODY. SHE REMOVED THE REMAINING PIECES HERSELF.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE REPORTER TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. ON OCTOBER 21, 2010 THE SMSS MAILED A LETTER REQUESTING THE REPORTER CONTACT MEDICAL SURVEILLANCE. ON (B)(6) 2010 AT 2:00 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 490 MG/DL ON THE REPORTED METER. SHE TOOK NO ACTIONS BASED ON THAT ELEVATED METER READING. FIVE MINUTES LATER, THE PATIENT EXPERIENCED THE SYMPTOM OF A SEIZURE. WITHIN THIRTY MINUTES THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM, WHERE HER BLOOD GLUCOSE LEVEL WAS TESTED TO BE 398 MG/DL USING A HOSPITAL METER. THE PATIENT WAS TREATED WITH GLUCOSE TABLETS. IT IS UNCLEAR WHY THE PATIENT WOULD HAVE BEEN TREATED WITH GLUCOSE WITH A BLOOD GLUCOSE LEVEL OF 398 MG/DL. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S EXPECTED BLOOD GLUCOSE READINGS, TO CONFIRM HER TREATMENT IN THE EMERGENCY ROOM, HER DIABETES MEDICATION REGIMEN, THE PATIENT'S BLOOD GLUCOSE READINGS PRIOR TO THE ONSET OF SYMPTOMS, AND WHAT MEALS AND MEDICATIONS WERE TAKEN PRIOR TO THE ONSET OF SYMPTOMS. TROUBLESHOOTING REVEALED THE PATIENT HAD NOT PROGRAMMED THE METER WITH THE CORRECT CALIBRATION CODE NUMBER FOR THE LOT OF TEST STRIPS IN USE, WHICH CAN CAUSE INACCURATE READINGS. THE TEST RESULTS FELL WITHIN EXPECTED VALUES FOR METER-TO-METER ACCURACY TESTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED A SEIZURE, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCOSE AFTER SHE OBTAINED AN ELEVATED METER READING ON THE REPORTED METER. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3043975

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R