FDA Adverse Event
Malfunction
Summary report: N
AMNISURE ROM TEST
MDR report key: 21676064
·
Received March 24, 2025
Report
- Report Number
- 21676064
- Event Type
- Malfunction
- Date Received
- March 24, 2025
- Date of Event
- February 22, 2025
- Report Date
- March 7, 2025
- Manufacturer
- QIAGEN SCIENCES, INC.
- Product Code
- NQM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584446 | AMNISURE ROM TEST | IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) | NQM | QIAGEN SCIENCES, INC. | PACKAGE 5702192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |