FDA Adverse Event
Malfunction
Summary report: N
CONFIRM ANTI-PROGESTERONE RECEPTOR (PR) (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
MDR report key: 25159406
·
Received May 13, 2026
Report
- Report Number
- 2028492-2026-01879
- Event Type
- Malfunction
- Date Received
- May 13, 2026
- Date of Event
- April 20, 2026
- Report Date
- May 13, 2026
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Product Code
- MXZ
- UDI-DI
- 04015630972180
- PMA / PMN Number
- K103818
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE CONFIRM ANTI-PROGESTERONE RECEPTOR (PR) (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY RESULTS FOR PATIENT SAMPLES TESTED ON THE BENCHMARK ULTRA INSTRUMENT. IT WAS REPORTED THAT ABOUT 4 TO 5 CASES IN WHICH THEY OBTAINED AN ESTROGEN RECEPTOR (ER) NEGATIVE, PROGESTERONE RECEPTOR (PR) POSITIVE (WEAK INTENSITY, IN 10 TO 20% OF THE CELLS), AND HER2 NEGATIVE RESULT. THE ONCOLOGIST REQUESTED THAT THE TESTS BE REPEATED AT ANOTHER INSTITUTION, AS THEY CONSIDERED THE POSITIVE PROGESTERONE AND NEGATIVE ER RESULT UNUSUAL. THE NEW RESULTS WERE PR NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76077 | CONFIRM ANTI-PROGESTERONE RECEPTOR (PR) (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | IMMUNOHISTOCHEMISTRY ASSAY,ANTIBODY,PROGESTERONE RECEPTOR | MXZ | VENTANA MEDICAL SYSTEMS INC. | N00775 | 04015630972180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |