BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHTEK UBT KIT

    MDR report key: 4162880 · Received October 8, 2014

    Report

    Report Number
    3000718406-2014-00002
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    November 8, 2017
    Manufacturer
    OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ
    Product Code
    MSQ
    PMA / PMN Number
    P100025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON 25-SEPT-2014. PRODUCT INVESTIGATION WAS PERFORMED; RESULT PENDING (B)(4). FOLLOW-UP INFORMATION WAS RECEIVED ON 01-OCT-2014: THE PATIENT WAS ON CHEMOTHERAPY FOR PANCREATIC CANCER. THE REPORTER WANTED TO KNOW IF CHEMOTHERAPY WOULD AFFECT THE RESULT OF THE BREATHTEK TEST. THE REPEAT BREATHTEK TEST WAS NEGATIVE (AFTER ANTIBIOTIC THERAPY FOR A PREVIOUS H. PYLORI TEST). THE PATIENT'S HCP CONTACT INFORMATION WAS PROVIDED. FURTHER INFORMATION WILL BE REQUESTED.

    Description of Event or Problem · 1

    PANCREATIC CANCER [PANCREATIC CANCER] CASE DESCRIPTION: ON (B)(6) 2014, INFORMATION WAS RECEIVED FROM A MEDICAL ASSISTANT REGARDING A (B)(6) MALE PATIENT WHO RECEIVED ONE DOSE OF PRANACTIN CITRIC (DOSE UNK) ORALLY ON (B)(6) 2014 IN PREPARATION FOR THE BREATHTEK TEST FOR DETECTION OF H. PYLORI WITH A DYSPEPSIA DIAGNOSIS. THE MEDICAL ASSISTANT REPORTED THAT THE PATIENT WAS A HEALTHY MALE AND DID NOT HAVE ANY RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATION, OR PAST DRUG HISTORY. ON (B)(6) 2014, HE TESTED POSITIVE FOR H. PYLORI AND WAS PRESCRIBED UNKNOWN ANTIBIOTICS TO TREAT THE INFECTION. ON AN UNKNOWN DATE, HE WAS DIAGNOSED WITH PANCREATIC CANCER, STAGE 2 OR 3. HE IS CURRENTLY TAKING UNKNOWN PAIN AND NAUSEA MEDICATIONS, AS WELL AS "GEM" CHEMOTHERAPY AND "PLATINUM" CHEMOTHERAPY, ALL TO TREAT HIS CANCER DIAGNOSIS. HE IS CURRENTLY SCHEDULED TO BE RETESTED WITH PRANACTIN CITRIC TO DETERMINE ERADICATION OF H. PYLORI. AS OF (B)(6) 2014, HE IS SCHEDULED TO RETEST WITH PRANACTIN CITRIC AND CONTINUES TO EXPERIENCE PANCREATIC CANCER. FURTHER INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631555 BREATHTEK UBT KIT UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE MSQ OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ

    Patients

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