ADVERSE EVENT REPORTED BY DISTRIBUTOR IN (B)(6) ON (B)(6) 2015. A PATIENT AT (B)(6) WEEKS GESTATION WENT TO HOSP COMPLAINING OF SIGNS AND SYMPTOMS OF ROM THAT BEGAN 3 HOURS PRIOR TO HER ARRIVAL AT THE HOSP. AN AMNISURE TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE PATIENT WAS SENT HOME. THE PATIENT RETURNED TO A DIFFERENT HOSP 10 DAYS LATER COMPLAINING OF CONTINUED DISCHARGE. ANOTHER AMNISURE TEST WAS PERFORMED AND THE RESULT WAS AGAIN NEGATIVE. A SONOGRAM WAS THEN PERFORMED AND SHOWED A EXTREMELY LOW AFI. THE PREGNANCY WAS TERMINATED AND THE TWINS HAD DECEASED.
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Patient 1
THE COMPANY IS UNABLE TO OBTAIN INFO TO FURTHER INVESTIGATE THIS EVENT DUE TO A HOLIDAY IN (B)(6). THE COMPANY IS SUBMITTING THIS MDR IN COMPLIANCE WITH 21 CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFO, AS NECESSARY. OUR PRELIMINARY INVESTIGATION HAS IDENTIFIED THE FOLLOWING: THE INTENDED USE OF THE AMNISURE ROM TEST, AS WRITTEN IN THE PACKAGE INSERT, INDICATES THAT THE TEST IS AN AID IN THE DETECTION OF RUPTURE OF FETAL MEMBRANES (ROM) IN PREGNANT WOMEN. AS A DIAGNOSTIC AID, THERE IS AN EXPECTATION THAT PATIENT CARE IS BASED ON A MULTITUDE OF FACTORS/TESTS/ANALYSES. IN THIS CASE, AN INITIAL ULTRASOUND WOULD HAVE BEEN USEFUL AS AN ADDITIONAL TOOL IN DETERMINING ROM STATUS AND CLINICAL ACTIONS.; THE COMPANY PERFORMED TESTING ON RETAIN SAMPLES FOR THE LOTS IMPLICATED AND ALL RESULTS PASSED SPECIFICATIONS. ADDITIONALLY, BATCH RECORDS WERE REVIEWED AND ALL TESTING PASSED SPECIFICATIONS WITH NO DEVIATIONS NOTED.