SINCE A LOT NUMBER WAS NOT AVAILABLE, OTSUKA PROVIDED POTENTIAL PRANACTIN CITRIC BULK LOT NUMBERS CK3BP03A02, CL3BP03A02, CL3BP03A03, CL3BP03A04, CD4BP03A07, CD4BP03A08, CD4BP03A09, CD4BP03A11, CD4BP03A13, AND CF4BP03A02 TO CMIC FOR THE INVESTIGATION INTO THE BULK PRANACTIN CITRIC. ALL THE BATCH RECORDS WERE RE-REVIEWED BY CMIC AND NO DEVIATIONS OR ANOMALIES WERE NOTED FOR ALL THE BATCHES. ALL BATCHES MANUFACTURED AT CMIC CMO USA CORPORATION ARE MADE AND TESTED AS PER CGMP. THE BULK PRODUCTS WERE TESTED FOR ID AT CMIC AND THE FINISHED PRODUCT IS TESTED AND RELEASED BY OTSUKA UPON MEETING PRODUCT SPECIFICATION AND THEN SHIPPED TO CUSTOMER'S PACKAGING SITE. THERE HAVE BEEN NO PROCESS CHANGES OR CHANGES DEEMED TO IMPACT PROCESSING SHARP PACKAGING SOLUTIONS, THE POUCH FILLER: SINCE A LOT NUMBER WAS NOT AVAILABLE, OTSUKA PROVIDED POTENTIAL PRANACTIN CITRIC POUCH LOT NUMBERS 170, 173, 174, 175, 176, 177, 178, 179, 181, AND 182 TO SHARP PACKAGING SOLUTION TO EVALUATE THE PRANACTIN CITRIC POUCHES. A REVIEW OF THE PACKAGING RECORD FOR LOT SIZE AND PACKAGING DATE, NOTED ISSUES FOUND DURING PACKAGING AND IN-PROCESS QUALITY INSPECTIONS WAS PERFORMED FOR THE AFOREMENTIONED POTENTIAL PRANACTIN POUCH LOT NUMBERS. NO ISSUES WERE NOTED DURING ANY OF THE QUALITY IN-PROCESS INSPECTIONS AND ASSOCIATED PACKAGING RECORDS AND ALL CLEANS WERE FOUND ACCEPTABLE. THERE WERE NO RELATED INVESTIGATION REPORTS FOR PRANACTIN.
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Patient 1
EVENT VERBATIM [PREFERRED TERM] MISCARRIAGE [ABORTION SPONTANEOUS] , . CASE NARRATIVE:ON (B)(6) 2014, THIS CONSUMER REPORTED A POSSIBLE DRUG EXPOSURE DURING PREGNANCY. THIS CURRENTLY PREGNANT FEMALE CONSUMER OF UNKNOWN AGE STARTED PRANACTIC-CITRIC, 1 DOSE, ONCE, ON (B)(6) 2014 FOR A "CHRONIC SORE THROAT." THE PATIENT?S RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATIONS, AND PAST DRUG HISTORY WERE UNKNOWN. SHE HAD TAKEN 1 DOSE OF PRANACTIN-CITRIC ON (B)(6) 2014 AND STATED "I JUST FOUND OUT THAT I AM PREGNANT." IT WAS UNKNOWN IF THE CONSUMER WAS PREGNANT WHEN SHE RECEIVED BREATHTEK. IT WAS UNKNOWN IF THERE WAS ANY RELEVANT LABORATORY DATA. AS OF (B)(6) 2014, SHE WAS NOT CURRENTLY SCHEDULED TO TAKE ANOTHER BREATHTEK TEST. THE OUTCOME OF POSSIBLE DRUG EXPOSURE DURING PREGNANCY WAS UNKNOWN. LOT AND EXPIRATION DATE UNKNOWN. FOLLOW-UP RECEIVED FROM PHYSICIAN ON 11-FEB-2014: THIS (B)(6) FEMALE PATIENT (DATE OF BIRTH: (B)(6) ) TOOK PRANACTIN-CITRIC FOR THE BREATHTEK TEST ON (B)(6) 2014 AND ABOUT 2 DAYS LATER FOUND THAT SHE WAS PREGNANT (AS PREVIOUSLY REPORTED). ON (B)(6) 2014 THE MOTHER HAD A BASIC PRENATAL PROFILE INCLUDING A TEST FOR SEXUALLY TRANSMITTED DISEASES WHICH WAS NEGATIVE, AND A COMPLETE BLOOD COUNT WITH NORMAL RESULTS (NOS). ON AN UNKNOWN DATE IN 2014, THE MOTHER HAD AN ULTRASOUND WHICH WAS APPROPRIATE FOR A 6 WEEK PREGNANCY. THE MOTHER'S MEDICAL HISTORY: ANXIETY AND HAVING A HEALTHY BABY BEFORE. THE MOTHER'S CONCOMITANT MEDICATION: VITAMINS, BUT NO PRESCRIPTION MEDICATIONS. AS OF (B)(6) 2014 THE MOTHER WAS NOT ON PRANACTIN-CITRIC AND THERE WERE NO CONCERNS ABOUT THE PREGNANCY AT THIS TIME. PRODUCT QUALITY COMPLAINT FOLLOW-UP RECEIVED 03MAR2015: ON (B)(6) 2014, A PREGNANT FEMALE CONSUMER REPORTED A POSSIBLE DRUG EXPOSURE DURING PREGNANCY. THE PREGNANT FEMALE CONSUMER OF UNKNOWN AGE STARTED PRANACTIN-CITRIC, 1 DOSE, ONCE, ON (B)(6) 2014 FOR A "CHRONIC SORE THROAT." SHE HAD TAKEN 1 DOSE OF PRANACTIN-CITRIC ON (B)(6) 2014 AND STATED "I JUST FOUND OUT THAT I AM PREGNANT." IT WAS UNKNOWN IF THE CONSUMER WAS PREGNANT WHEN SHE RECEIVED BREATHTEK. IT WAS UNKNOWN IF THERE WAS ANY RELEVANT LABORATORY DATA. IT WAS REPORTED IN THIS CASE THAT AS OF (B)(6) 2014, SHE WAS NOT CURRENTLY SCHEDULED TO TAKE ANOTHER BREATHTEK TEST. THE OUTCOME OF POSSIBLE DRUG EXPOSURE DURING PREGNANCY WAS UNKNOWN. LOT AND EXPIRATION DATE UNKNOWN. IT WAS ALSO NOTED THAT A FOLLOW-UP WAS RECEIVED FROM PHYSICIAN ON (B)(6) 2014 WITH THE FOLLOWING STATEMENT: ?THIS (B)(6) FEMALE PATIENT (DATE OF BIRTH: (B)(6) TOOK PRANACTIN-CITRIC FOR THE BREATHTEK TEST ON (B)(6) 2014 AND ABOUT 2 DAYS LATER FOUND THAT SHE WAS PREGNANT (AS PREVIOUSLY REPORTED). ON (B)(6) 2014 THE MOTHER HAD A BASIC PRENATAL PROFILE INCLUDING A TEST FOR SEXUALLY TRANSMITTED DISEASES WHICH WAS NEGATIVE, AND A COMPLETE BLOOD COUNT WITH NORMAL RESULTS (NOS). ON AN UNKNOWN DATE IN 2014, THE MOTHER HAD AN ULTRASOUND WHICH WAS APPROPRIATE FOR A 6 WEEK PREGNANCY. THE MOTHER'S MEDICAL HISTORY: ANXIETY AND HAVING A HEALTHY BABY BEFORE. THE MOTHER'S CONCOMITANT MEDICATION: VITAMINS, BUT NO PRESCRIPTION MEDICATIONS?. FURTHERMORE, THE FOLLOWING WAS ALSO NOTED IN THIS CASE: ?AS OF (B)(6) 2014 THE MOTHER WAS NOT ON PRANACTIN-CITRIC AND THERE WERE NO CONCERNS ABOUT THE PREGNANCY AT THIS TIME?. THIS CASE ALSO NOTED THAT THERE WAS NO ADVERSE EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ?DOCUMENTATION FAILURE? (NO INFORMATION AVAILABLE) REGARDING THE PRESCRIBING INFORMATION. THE COMPLAINT IS CONFIRMED. THIS CASE WAS FORWARDED AT THE TIME IT WAS RECEIVED TO CS&PV FOR SAFETY REVIEW AND ASSIGNED ARGUS NUMBER US-2014-10138. BASED ON THE PRODUCT QUALITY COMPLAINT INVESTIGATION RESULTS, THE ROOT CAUSE OF THE COMPLAINT IS "DOCUMENTATION FAILURE" AND THERE IS NO REPORTED DEVICE MALFUNCTION. THIS REPORT FROM PQC PERSPECTIVE DOES NOT MEET THE REQUIREMENT FOR MDR REPORTABILITY. THE COMPLAINT TYPE IS COMPLAINT AND AE. THIS REPORT WILL BE FORWARDED TO SAFETY (CS&PV). THIS REPORTED ISSUE WILL BE SENT TO THE DESIGN PROJECT TEAM AS PART OF THE MONTHLY RECONCILIATION PROCESS. THE PRODUCT QUALITY COMPLAINT WAS CLOSED. FOLLOW-UP RECEIVED 16MAR2015: A FOLLOW-UP CALL WAS MADE TO THE PATIENT. THE PATIENT STATED THAT SHE EXPERIENCED MISCARRIAGE AFTER TAKING BREATHTEK TEST. THE PATIENT DECLINED TO PROVIDE FURTHER DETAILS ABOUT THE INCIDENT AND REFUSED FURTHER CONTACT. OTSUKA CAUSALTIY STATEMENT: THIS CASE HAS LIMITED INFORMATION. FROM THE CHRONOLOGY PROVIDED THE PATIENT HAD A SINGLE EXPOSURE TO THE DRUG (BREATHTEK) WHILE PREGNANT ON (B)(6) 2014. APPROXIMATELY THREE WEEKS LATER THE HISTORY NOTES THAT THERE WERE NO CONCERNS ABOUT THE PREGNANCY, AND AN ULTRASOUND WAS DONE AT AN UNKNOWN DATE WHICH WAS APPROPRITE FOR A SIX WEEK PREGNANCY. GIVEN THE SINGLE DOSE OF EXPOSURE AND CONTINUATION OF PREGNANCY FOR AT LEAST 3 MORE WEEKS POST-EXPOSURE IT IS UNLIKELY THAT BREATHTEK WAS CAUSALLY RELATED TO THE EVENT OF SPONTANEOUS ABORTION. HAVING SAID THAT, THE SPONTANEOUS REPORTING IMPLIES CAUSALITY. OTSUKA CAUSALITY ASSESSMENT: THE E...