MalfunctionNQM
AMNISURE ROM TEST
Received Mar 24, 2025 · Event occurred Feb 22, 2025
Report 21676064 · MDR key 21676064
Device
Generic name
Immunoassay For Detection Of Amniotic Fluid Protein(s)
Manufacturer
Qiagen Sciences, Inc.Catalog number
1073557
Lot number
PACKAGE 5702192
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REGISTERED NURSE (RN) ATTEMPTING TO OBTAIN AMNISURE TEST NOTED THERE WAS NO FLUID IN THE TEST SOLUTION VIAL THAT WAS REMOVED FROM A NEWLY OPENED PACKAGE. THE PACKAGING LISTED LOT #57802192, EXPIRATION DATE 12/29/2026. THE TEST VIAL SOLUTION HAD A DIFFERENT EXPIRATION DATE OF 12/6/2027 AND LOT#575015496. REF # 1073557 ON TEST VIAL. RN OBTAINED A NEW AMINISURE TEST TO USE ON THE PATIENT. THIS EVENT WAS A GOOD CATCH AND DID NOT IMPACT THE CARE AND TREATMENT OF THE PATIENT.