BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHTEK UBT KIT

    MDR report key: 6972704 · Received October 24, 2017

    Report

    Report Number
    3000718406-2017-00003
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    October 7, 2017
    Report Date
    October 11, 2017
    Manufacturer
    OTSUKA AMERICA PHARMACEUTICALS, INC.
    Product Code
    MSQ
    PMA / PMN Number
    P100025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP 1 WAS ORIGINALLY SUBMITTED WITH INCORRECT REPORT NUMBER (3000718-2017-00001) WHICH WAS LATER CORRECTED AND SUBMITTED AS FOLLOW-UP 2. ALL INFORMATION FROM FOLLOW-UP 1, FOLLOW-UP 2, AND FOLLOW-UP 3 HAVE BEEN PROCESSED AND SUBMITTED TOGETHER.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] VOMITING [VOMITING] , STOMACH HURTS [ABDOMINAL PAIN UPPER] , . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED FROM (B)(4) ON (B)(4) 2017. ON (B)(4) 2017, A MOTHER REPORTED, THAT A (B)(6) YEAR-OLD FEMALE PATIENT (DAUGHTER) STARTED BREATHTEK UBT KIT (PRANACTIN CITRIC) ON (B)(6) 2017, AT FULL DOSE, UNKNOWN STRENGTH, ONCE, ORALLY FOR THE INDICATION OF H. PYLORI. RELEVANT MEDICAL HISTORY INCLUDED H. PYLORI INFECTION, WHICH WAS TREATED WITH THREE UNKNOWN ANTIBIOTICS AND ONE UNKNOWN ANTACID. THE PATIENT DID NOT HAVE ANY RELEVANT CONCOMITANT MEDICATION. LABORATORY RESULTS WERE UNKNOWN. LOT NUMBER AND EXPIRY DATE WERE NOT PROVIDED. ON (B)(6) 2017, THE DAUGHTER CONSUMED THE PRANACTIN-CITRIC SOLUTION AND BEGAN VOMITING ABOUT TWENTY MINUTES AFTER DRINKING IT. THE DAUGHTER ALSO COMPLAINED ABOUT HER STOMACH HURTING. THE MOTHER REPORTED THAT THE DAUGHTER VOMITED ABOUT 23 TIMES ON (B)(6) 2017 AND ABOUT EIGHT TIMES SINCE THEN. AFTER THAT SHE DID NOT VOMIT AS MUCH AS BEFORE. ON THE SAME DAY, (B)(6) 2017, SHE ALSO WENT TO THE EMERGENCY ROOM WHERE SHE WAS TREATED WITH INTRAVENOUS (IV) FLUIDS AND AN UNKNOWN MEDICATION FOR NAUSEA. IT IS UNKNOWN, IF THE PATIENT COMPLETED THE BREATHTEK TEST. AS OF (B)(6) 2017, THE PATIENT HAS NOT CONSUMED THE PRANACTIN-CITRIC SOLUTION AGAIN AND HER VOMITING WAS IMPROVING. THE OUTCOME OF HER STOMACH HURTING WAS UNKNOWN. COMPANY COMMENT: THE EVENTS VOMITING WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND STOMACH HURTING AS NON-SERIOUS. BOTH THE EVENTS WERE ASSESSED AS RELATED TO BREATHTEK BASED ON TEMPORAL ASSOCIATION AND LACK OF CONFOUNDING FACTORS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. FOLLOW-UP WAS RECEIVED FROM THE PATIENT'S MOTHER BY PQC ON (B)(6) 2017. THE PATIENT'S MOTHER STATED THAT HER DAUGHTER TOOK THE BREATHTEK TEST ABOUT A WEEK AND A HALF AGO. SHE BEGAN VOMITING ABOUT TWENTY MINUTES AFTER DRINKING THE SOLUTION AND COMPLAINED THAT HER STOMACH WAS HURTING AT THAT TIME. SHE VOMITED MANY TIMES THE DAY OF THE TEST AND WAS VERY, VERY SICK FOR THE FOLLOWING 3 OR 4 DAYS. SHE VOMITED A FEW TIMES MORE OVER THE NEXT 3 OR 4 DAYS IMMEDIATELY AFTER THE TEST, BUT THE CONDITION AND ISSUES HAVE IMPROVED AFTER THAT. THE PATIENT HAS NOT BEEN ADMINISTERED A BREATHTEK TEST IN THE PAST. THE PATIENT'S MOTHER STATED THAT TO HER KNOWLEDGE, THE LAB DID NOT HAVE ANY ISSUES WITH THE KIT ITSELF OR WITH THE ADMINISTRATION OF THE TEST. THE REPORTER DID NOT KNOW THE LOT NUMBER OF THE KIT AND BELIEVED THE KIT WAS DISCARDED AFTER THE TEST WAS ADMINISTERED. THE OUTCOME OF HER STOMACH HURTING WAS UNKNOWN AND VOMITING WAS IMPROVED. (B)(4) CAUSALITY ASSESSMENT: : THE EVENT VOMITING WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND STOMACH HURTING AS NON-SERIOUS. BOTH THE EVENTS WERE ASSESSED AS RELATED TO BREATHTEK BASED ON TEMPORAL ASSOCIATION. HOWEVER, UNDERLYING CONDITION OF H.PYLORI INFECTION IS A CONFOUNDING FACTOR. PRODUCT QUALITY COMPLAINT FOLLOW-UP RECEIVED ON 12-DEC-2017 VIA CLOSED PRODUCT QUALITY COMPLIANT (PQC) RECORD: BATCH RECORD REVIEW: BATCH RECORDS WERE REVIEWED FOR POTENTIAL PRANACTIN-CITRIC BULK GRANULATION LOT NUMBER(S) [CK5BP03A08, CK5BP03A10, CK5BP03A11, CA6BP03A06, CA6BP03A07, CA6BP03A08, CC6BP03A09, CC6BP03A10, CC6BP03A11, CC6BP03A13, CC6BP03A14, CC6BP03A15, AND CD6BP03A11] AND NO MANUFACTURING RELATED DEVIATIONS, ANOMALIES OR OBSERVATIONS WERE NOTED FOR THIS BATCH. ALL BATCHES MANUFACTURED AT CMIC CMO USA CORPORATION ARE MADE AND TESTED AS PER CGMP. ALL BATCH RECORDS WERE QA REVIEWED AND APPROVED BY (B)(4) QA. THERE HAVE BEEN NO PROCESS CHANGES OR CHANGES DEEMED TO IMPACT PROCESSING. THE ANNUAL PRODUCT REVIEW FOR THIS PRODUCT REPORTING FOR 2015 & 2016 REPORTS THAT ALL IN-PROCESS TEST DATA WERE WITHIN SPECIFICATIONS WITH NO DISCERNIBLE TREND. THE BULK PRODUCT WAS TESTED FOR ID AT CMLC AND MET THE PRODUCT BULK SPECIFICATION. DESC/EVALUATION OF COMP SAMPLE: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR THE SUBJECT COMPLAINT. THEREFORE, AN EVALUATION OF COMPLAINT SAMPLE COULD NOT BE PERFORMED. RETAIN SAMPLE EVALUATION: A LOT NUMBER WAS NOT PROVIDED FOR THE SUBJECT COMPLAINT; THEREFORE RETAIN TESTING IS NOT REQUIRED. OPDC-GPQ REVIEWED THE CURRENT STABILITY DATA FOR PRANACTIN-CITRIC. THE STABILITY DATA EVALUATION SHOWED THE PRODUCT BEHAVIOR CONTINUES TO BE WITHIN THE ESTABLISHED SPECIFICATIONS. BASED ON THE PRODUCT QUALITY COMPLAINT INVESTIGATION RESULTS, THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. (B)(4) CAUSALITY ASSESSMENT: : PER PQC REPORT, THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. FOLLOW-UP INFORMATION (QUERY ANSWER) RECEIVED ON (B)(6) 2018 BY TREATING PHYSICIAN: PATIENT WAS NOT HOSPITALISED. (B)(4) CAUSALITY ASSESSMENT: PER PQC REPORT, THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED., COMMENT: NOT APPLICABLE.

    Description of Event or Problem · 1

    THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED FROM ((B)(6)) ON 11-OCT-2017. ON 11-OCT-2017, A MOTHER REPORTED, THAT A (B)(6) FEMALE PATIENT (DAUGHTER) STARTED BREATHTEK UBT KIT (PRANACTIN CITRIC) ON (B)(6) 2017, AT FULL DOSE, UNKNOWN STRENGTH, ONCE, ORALLY FOR THE INDICATION OF H. PYLORI. RELEVANT MEDICAL HISTORY INCLUDED H. PYLORI INFECTION, WHICH WAS TREATED WITH THREE UNKNOWN ANTIBIOTICS AND ONE UNKNOWN ANTACID. THE PATIENT DID NOT HAVE ANY RELEVANT CONCOMITANT MEDICATION. LABORATORY RESULTS WERE UNKNOWN. LOT NUMBER AND EXPIRY DATE WERE NOT PROVIDED. ON (B)(6) 2017, THE DAUGHTER CONSUMED THE PRANACTIN-CITRIC SOLUTION AND BEGAN VOMITING ABOUT TWENTY MINUTES AFTER DRINKING IT. THE DAUGHTER ALSO COMPLAINED ABOUT HER STOMACH HURTING. THE MOTHER REPORTED THAT THE DAUGHTER VOMITED ABOUT 23 TIMES ON (B)(6) 2017 AND ABOUT EIGHT TIMES SINCE THEN. AFTER THAT SHE DID NOT VOMIT AS MUCH AS BEFORE. ON THE SAME DAY, (B)(6) 2017, SHE ALSO WENT TO THE EMERGENCY ROOM WHERE SHE WAS TREATED WITH INTRAVENOUS (IV) FLUIDS AND AN UNKNOWN MEDICATION FOR NAUSEA. IT IS UNKNOWN, IF THE PATIENT COMPLETED THE BREATHTEK TEST. AS OF 11-OCT-2017, THE PATIENT HAS NOT CONSUMED THE PRANACTIN-CITRIC SOLUTION AGAIN AND HER VOMITING WAS IMPROVING. COMPANY COMMENT: THE EVENTS VOMITING WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND STOMACH HURTING AS NON-SERIOUS. BOTH THE EVENTS WERE ASSESSED AS RELATED TO BREATHTEK BASED ON TEMPORAL ASSOCIATION AND LACK OF CONFOUNDING FACTORS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752514 BREATHTEK UBT KIT UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE MSQ OTSUKA AMERICA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other