AMNISURE
Received Nov 18, 2022 · Event occurred Nov 15, 2022
Report MW5113380 · MDR key 15834368
Device
Generic name
Immunoassay For Detection Of Amniotic Fluid Protein(s).
Manufacturer
QiagenLot number
57203698
Product problems
- False Negative Result
Patient
Unknown
- Fluid Discharge
- Fluid Discharge
Narrative
Description of Event or Problem
PT CAME INTO TRIAGE REPORTING QUESTIONABLE RUPTURE OF MEMBRANES. PT DENIED HAVING LEAKING ON CHUX ON ADMISSION. DR (B)(6) CALLED FOR AMNISURE. AMNISURE PERFORMED, NOTED TO HAVE FLUID COMING OUT OF HOLLOW END OF Q-TIP DURING PROCEDURE. THIS RN NITRAZINED FLUID LEAKING FROM AMISURE Q-TIP AND IMMEDIATELY POSITIVE. WHILE AWAITING 10 MIN FOR AMNISURE PT REPORT LARGE AMOUNT OF LEAKING ON CHUX, CHUX CHANGED PER RN AND WERE SATURATED WITH FLUID, NITRAZINE POSITIVE OF FLUID ON CHUX. AFTER 10 MIN NOTED AMNISURE TO BE NEGATIVE. DR (B)(6) DECIDED THEN TO PERFORM FERNING. MD PERFORMED FERN TEST AND REPORTED BACK PT WAS POSITIVE FOR FERNING AND THUS RUPTURE OF MEMBRANES. FDA SAFETY REPORT ID # (B)(4).