PATIENT ARRIVED AT THE HOSPITAL ON (B)(6) 2015. A VISUAL EXAM OF THE VAGINA WAS COMPLETED; HEAVY YELLOW DISCHARGE WAS SEEN BUT NO SIGNS OF AMNIOTIC FLUID LEAKAGE. AN AMNISURE TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE PATIENT WAS SENT HOME. THE PATIENT RETURNED TO THE HOSPITAL THE NET DAY AND PRESENTED WITH A SEVERE INFECTION. MECONIUM WAS VISIBLE. THE PATIENT DELIVERED AND WENT INTO A SEPTIC SHOCK. AFTER DELIVERY, THE PATIENT WAS PLACED IN ICU AND ADMINISTERED ANTIBIOTICS. THE INFANT WAS ALSO PLACED IN NICU AND ADMINISTERED ANTIBIOTICS. BOTH PATIENTS RECOVERED AND WERE RELEASED FROM THE HOSPITAL.
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Patient 1
THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT THE RESULT OBTAINED FROM THE DEVICE DID NOT CONTRIBUTE OR CAUSE A SERIOUS INJURY TO THE PATIENT. THE COMPANY IS SUBMITTING THIS MDR FOR INFORMATION PURPOSES IN COMPLIANCE WITH 21 CFR 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFORMATION, AS NECESSARY. BASED ON THE INFORMATION PROVIDED, IT IS HIGHLY SUSPECTED THAT DESIGNATED PARTS OF THE PROCEDURE AND LIMITATIONS OF THE TEST WERE NOT FOLLOWED. THE HEALTHCARE FACILITY REPORTED THAT THEY ARE ACTIVELY CORRELATING AMNISURE WITH ANOTHER DIAGNOSTIC TEST FOR TOM. THE OTHER TEST HAS A 15 SECOND COLLECTION REQUIREMENT, WHEREAS AMNISURE HAS A 60 SECOND COLLECTION. A NURSE AT THIS FACILITY ADMITTED TO PERFORMING 15 SECOND COLLECTIONS FOR BOTH TESTS. WHILE IT IS UNCONFIRMED WHAT THE COLLECTION TIME WAS FOR THE SPECIFIC PATIENT IN QUESTION, IT IS LIKELY THAT THE COLLECTION TIME WAS SHORTENED DUE TO CONFUSION WHEN RUNNING THE TESTS ONE AFTER ANOTHER. ADDITIONALLY, THE HEALTHCARE FACILITY REVIEWED THE PATIENT CHART AND BELIEVES IT IS POSSIBLE THE PATIENT REPORTED SIGNS OF RUPTURE MORE THAN 12 HOURS PRIOR TO TESTING.