THE KNOWN INFORMATION IS AS FOLLOWS: PATIENT AT (B)(6) GESTATION PRESENTED AT THE HOSPITAL AND WAS TESTED USING AMNISURE. BLOOD WAS PRESENT IN THE SAMPLE. THE AMNISURE RESULT WAS NEGATIVE. AMNIOTIC FLUID LEVELS WERE DETERMINED TO BE INCREASING VIA AFI, AND PATIENT WAS RELEASED FROM THE HOSPITAL AFTER AN UNSPECIFIED OBSERVATION PERIOD. SOMETIME WITHIN A WEEK (UNSPECIFIED), THE PATIENT RETURNED TO THE HOSPITAL AND DELIVERED PREMATURELY, RESULTING IN FETAL DEATH. CHORIOAMNIONITIS WAS PRESENT AT THE TIME OF DELIVERY. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. IT IS LIKELY THAT THE AMNISURE RESULT WAS CORRECT SINCE OTHER CLINICAL TESTING AND ASSESSMENTS ALSO DID NOT INDICATE ROM. THE AMNISURE TEST DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT; HOWEVER, IN AN ABUNDANCE OF CAUTION, AN MDR IS BEING SUBMITTED.
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Patient 1
A REPORT OF A POTENTIAL FALSE NEGATIVE AMNISURE RESULT WAS RECEIVED THROUGH A QIAGEN SALES REPRESENTATIVE. A PATIENT AT (B)(6) GESTATION WAS TESTED WITH AMNISURE AND ANOTHER CLINICAL METHOD, BOTH NOT INDICATING ROM. PATIENT WAS ADMITTED FOR OBSERVATION AND SUBSEQUENTLY RELEASED. SHE RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS LATER AND DELIVERED PREMATURELY, RESULTING IN FETAL DEATH.