BEUDAMED
    FDA Adverse Event Summary report: N

    BREATHTEK (UBT)

    MDR report key: 2126486 · Received May 31, 2011

    Report

    Report Number
    3000718406-2011-00002
    Date Received
    May 31, 2011
    Report Date
    May 31, 2011
    Product Code
    MSQ
    PMA / PMN Number
    K014225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DECLINED FURTHER INFORMATION FOR THE SAFETY REPORT INCLUDING FOLLOW-UP, CONCOMITANT MEDICATIONS AND PROVIDER INFORMATION.

    Description of Event or Problem · 1

    CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED TAKING AN UNKNOWN DOSE OF THE PRANACTIN-CITRIC (13C-UREA) SOLUTION ON (B)(6) 2011, FOR THE PURPOSE OF COMPLETING THE BREATHTEK TEST TO CHECK FOR H. PYLORI. THE PATIENT'S MEDICAL HISTORY INCLUDES AN "ATTACK" OR INFECTION OF H. PYLORI IN 2003. IN (B)(6) 2011, HER DOCTOR DREW BLOOD TWO WEEKS PRIOR TO THE BREATHTEK TEST WHICH SHOWED A POSITIVE RESULT. THE PATIENT'S ALSO HAS A HISTORY OF HYPERTENSION. THE PATIENT'S BLOOD PRESSURE WAS 135/75 WHEN PREVIOUSLY TAKING ONLY ONE DOSE OF TOPROL XL DAILY. IN APPROXIMATELY 2003, THE PATIENT HAD AN "ATTACK" OR INFECTION OF H. PYLORI. IN (B)(6) 2011, THE PATIENT'S PHYSICIAN DREW BLOOD TWO WEEKS PRIOR TO THE BREATHTEK TEST WHICH SHOWED A POSITIVE RESULT. THE PATIENT'S RELEVANT CONCOMITANT MEDICATIONS ARE UNKNOWN. IN (B)(6) 2011, A WEEK AFTER TAKING THE BREATHTEK TEST, THE PATIENT'S BLOOD PRESSURE "SPIKED" TO 223/114. THE PATIENT'S DOCTOR INCREASED THE DOSAGE OF TOPROL XL TO ONE IN THE MORNING AND ONE IN THE EVENING. THE PATIENT'S BLOOD PRESSURE WENT DOWN TO 175/80. AS OF (B)(6) 2011, THE PATIENT'S BLOOD PRESSURE WAS STILL HIGHER THAN PRIOR TO TAKING BREATHTEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHTEK (UBT) NONE MSQ

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other TOPROL XL (METOPROLOL SUCCINATE) ((B)(6))| TOPROL XL (METOPROLOL SUCCINATE) ((B)(6))