AMNISURE ROM TEST

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED BY USER. THEY DID NOT USE ANY OTHER ASSESSMENTS IN CONJUNCTION WITH THE AMNISURE TEST FOR DIAGNOSIS OF ROM. A SIGNIFICANT AMOUNT OF BLOOD WAS PRESENT IN THE SECOND AMNISURE TEST SAMPLE. WHEN THERE IS A SIGNIFICANT PRESENCE OF BLOOD ON THE SWAB, THE TEST CAN MALFUNCTION AND IS NOT RECOMMEND. OUR INVESTIGATION CONCLUDED THAT THE KIT LOT IS FUNCTIONING AS EXPECTED, AND NO CORRECTIVE ACTIONS ARE NEEDED.

Additional Manufacturer Narrative

THE LOT APPEARS TO BE PERFORMING WITHIN SPECIFICATIONS. NO OTHER CUSTOMERS HAVE REPORTED ISSUES WITH THIS LOT. QIAGEN'S OVERALL EVALUATION DOES NOT INDICATE A SYSTEMIC PROBLEM WITH THIS LOT. THE TEST WAS PERFORMED AFTER THE PATIENT HAD REPORTED FLUID LEAKAGE FOR SEVERAL DAYS. THE AMNISURE ROM TEST INSTRUCTIONS FOR USE STATES THE FOLLOWING IN THE LIMITATIONS OF THE TEST SECTION: 1. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION. 2. FAILURE TO DETECT MEMBRANE RUPTURE DOES NOT ASSURE THE ABSENCE OF MEMBRANE RUPTURE. 3. IN RARE CASES, WHEN A SAMPLE IS TAKEN 12 HOURS OR LATER AFTER A RUPTURE HAS OCCURRED AND THE LEAKAGE OF AMNIOTIC FLUID HAS STOPPED, THE TEST MAY NOT DETECT ROM DUE TO SEVERAL FACTORS, INCLUDING (BUT NOT LIMITED TO) RESEALING OF THE RUPTURE, DENATURING ANTIGEN, ETC. PERIODIC RETESTING IN SUCH CASES MAY BE ADVISABLE.

Description of Event or Problem

A CUSTOMER REPORTED A FETAL DEATH TO ANSM AFTER AN UNEXPECTED NEGATIVE AMNISURE RESULT. MOTHER REPORTED LEAKAGE FOR SEVERAL DAYS PRIOR TO TESTING.