FLEX MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR CLONE PGR 636 READY-TO-US
Report
- Report Number
- 3003423869-2025-00029
- Event Type
- Malfunction
- Date Received
- May 9, 2025
- Date of Event
- March 12, 2025
- Report Date
- October 22, 2025
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- MXZ
- UDI-DI
- 05700573000920
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION TO MANUFACTURER REGISTRATION NUMBER, CORRECT NUMBER IS 2916205.
THE FOLLOWING FIELDS WERE UPDATED.
THE FOLLOWING FIELDS WERE UPDATED: B4, B5, G3, G6, H2, H11.
ON (B)(6) 2025, THE CUSTOMER CONTACTED AGILENT FOR ASSISTANCE IN ADJUSTING THE PROTOCOL FOR PROGESTERONE RECEPTOR (PR). AN AGILENT APPLICATION ENGINEER (AE) VISITED THE SITE THE FOLLOWING DAY AND HELPED TO OPTIMIZE THE PROTOCOL. IT WAS ON (B)(6) 2025 WHILE THE AE WAS ON SITE DOING VERIFICATION EXPERIMENTS, THE CUSTOMER REPORTED CONFLICTING RESULTS OF THE PR RESULTS FOR 1 PATIENT BETWEEN THIS HOSPITAL AND ANOTHER HOSPITAL. THE INITIAL RUN WAS COMPLETED ON APPROXIMATELY (B)(6) 2025 AND SHOWED POSITIVE PR STAINING. THE PATIENT INDEPENDENTLY WENT TO ANOTHER HOSPITAL AND RECEIVED STAINING RESULTS THAT SHOWED NEGATIVE PR STAINING, THEREBY PRESENTING A POSSIBLE FALSE POSITIVE RESULT. THE INITIAL RUN'S RESULTS WERE NEGATIVE ESTROGEN RECEPTOR (ER) AND POSITIVE PR. THE HOSPITAL'S STANDARD PROCEDURE STATES THEY NEED TO RE-RUN THE TEST TO RULE OUT / PREVENT FALSE RESULTS FROM BEING RELEASED. THE HOSPITAL RE-RAN THE SAMPLE AND RECEIVED THE SAME RESULTS, NEGATIVE ER AND POSITIVE PR. THE RESULTS WERE PROVIDED TO THE PATIENT. THE PATIENT THEN TOOK THESE RESULTS TO ANOTHER HOSPITAL. THE OTHER HOSPITAL AGREED THAT THE INITIAL RESULTS WERE NEGATIVE ER AND POSITIVE PR. WHILE THE INITIAL HOSPITAL STATED 10% OF NUCLEI WERE STAINED (1% OR HIGHER IS POSITIVE STAINING PER THE IFU) THE OTHER HOSPITAL STATES ONLY 5% OF NUCLEI WERE STAINED. THE OTHER HOSPITAL RE-RAN THE PATIENT'S TISSUE ON A COMPETITOR PLATFORM WITH A COMPETITOR REAGENT AND RECEIVED NEGATIVE ER AND NEGATIVE PR, I.E. A NEGATIVE RESULT. THE PATIENT RETURNED TO THE INITIAL HOSPITAL NOTIFYING THEM OF THE RESULTS AND INQUIRING ABOUT WHY THE STAINING RESULTS WERE DIFFERENT. IT WAS CONFIRMED THE PATIENT DID NOT RECEIVE TREATMENT IN THE INITIAL HOSPITAL. HOWEVER, THE HEALTH STATUS OF THE PATIENT IS UNKNOWN AND THE PATIENT HAS NOT SHARED ANY FURTHER INFORMATION WITH THE HOSPITAL. THE AE FOUND NO ISSUE WITH THE INSTRUMENT AND THAT THE CUSTOMER IS STAINING THE TISSUE CORRECTLY. THE REAGENT HAD NO ISSUE WITH IT AS THE AE VERIFIED PROPER STAINING BY USING DIFFERENT BATCH NUMBERS AND OTHER BRANDS OF ANTIBODIES AND THE RESULTS WERE CONSISTENTLY POSITIVE. THE WERE NO PROBLEMS IN STAINING THE EXTERNAL AND INTERNAL CONTROLS AS THEIR RESULTS WERE ALSO CONSISTENTLY POSITIVE. THE NEGATIVE STAINING RESULT OBTAINED BY THE OTHER HOSPITAL WAS NOT ABLE TO BE REPRODUCED. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE NEW RELEVANT INFORMATION BECOMES AVAILABLE.
ON (B)(6) 2025, THE CUSTOMER CONTACTED AGILENT FOR ASSISTANCE IN ADJUSTING THE PROTOCOL FOR PROGESTERONE RECEPTOR (PR). AN AGILENT APPLICATION ENGINEER (AE) VISITED THE SITE THE FOLLOWING DAY AND HELPED TO OPTIMIZE THE PROTOCOL. IT WAS ON (B)(6) 2025 WHILE THE AE WAS ON SITE DOING VERIFICATION EXPERIMENTS, THE CUSTOMER REPORTED CONFLICTING RESULTS OF THE PR RESULTS FOR 1 PATIENT BETWEEN THIS HOSPITAL AND ANOTHER HOSPITAL. THE INITIAL RUN WAS COMPLETED ON APPROXIMATELY MARCH 12, 2025, AND SHOWED POSITIVE PR STAINING. THE PATIENT INDEPENDENTLY WENT TO ANOTHER HOSPITAL AND RECEIVED STAINING RESULTS THAT SHOWED NEGATIVE PR STAINING, THEREBY PRESENTING A POSSIBLE FALSE POSITIVE RESULT. THE INITIAL RUN'S RESULTS WERE NEGATIVE ESTROGEN RECEPTOR (ER) AND POSITIVE PR. THE HOSPITAL'S STANDARD PROCEDURE STATES THEY NEED TO RE-RUN THE TEST TO RULE OUT / PREVENT FALSE RESULTS FROM BEING RELEASED. THE HOSPITAL RE-RAN THE SAMPLE AND RECEIVED THE SAME RESULTS, NEGATIVE ER AND POSITIVE PR. THE RESULTS WERE PROVIDED TO THE PATIENT. THE PATIENT THEN TOOK THESE RESULTS TO ANOTHER HOSPITAL. THE OTHER HOSPITAL AGREED THAT THE INITIAL RESULTS WERE NEGATIVE ER AND POSITIVE PR. WHILE THE INITIAL HOSPITAL STATED 10% OF NUCLEI WERE STAINED (1% OR HIGHER IS POSITIVE STAINING PER THE IFU) THE OTHER HOSPITAL STATES ONLY 5% OF NUCLEI WERE STAINED. THE OTHER HOSPITAL RE-RAN THE PATIENT'S TISSUE ON A COMPETITOR PLATFORM WITH A COMPETITOR REAGENT AND RECEIVED NEGATIVE ER AND NEGATIVE PR, I.E. A NEGATIVE RESULT. THE PATIENT RETURNED TO THE INITIAL HOSPITAL NOTIFYING THEM OF THE RESULTS AND INQUIRING ABOUT WHY THE STAINING RESULTS WERE DIFFERENT. IT WAS CONFIRMED THE PATIENT DID NOT RECEIVE TREATMENT IN THE INITIAL HOSPITAL. HOWEVER, THE HEALTH STATUS OF THE PATIENT IS UNKNOWN AND THE PATIENT HAS NOT SHARED ANY FURTHER INFORMATION WITH THE HOSPITAL. THE AE FOUND NO ISSUE WITH THE INSTRUMENT NOR ANY ISSUES WITH THE REAGENT. THE AE VERIFIED PROPER STAINING BY USING DIFFERENT BATCH NUMBERS AND OTHER BRANDS OF ANTIBODIES AND THE RESULTS WERE CONSISTENTLY POSITIVE. THE WERE NO PROBLEMS IN STAINING THE EXTERNAL AND INTERNAL CONTROLS AS THEIR RESULTS WERE ALSO CONSISTENTLY POSITIVE. HOWEVER, IT WAS RECOMMENDED TO THE CUSTOMER TO VALIDATE THEIR STAINING PROTOCOL WITH A LARGER SAMPLE, GREATER THAN 10 CASES, TO ENSURE TEST ACCURACY. ADDITIONALLY, IT WAS CONFIRMED THAT THE CUSTOMER DID NOT USE ANY OTHER CONFIRMATORY PANELS OR TESTS, AS DIRECTED BY THE IFU, BEFORE RELEASING THE RESULT TO THE PATIENT. THE NEGATIVE STAINING RESULT OBTAINED BY THE OTHER HOSPITAL WAS NOT ABLE TO BE REPRODUCED, AND THE IMAGES OF THE NEGATIVE STAINING ARE NOT ABLE TO BE REVIEWED. AS NO ISSUES WERE FOUND WITH ANY AGILENT PRODUCT, AND THE CONTRADICTORY STAINING IS UNABLE TO BE REVIEWED, THE ROOT CAUSE FOR THE EVENT IS UNABLE TO BE DETERMINED.
ON (B)(6) 2025, THE CUSTOMER (B)(6) HOSPITAL CONTACTED AGILENT FOR ASSISTANCE IN ADJUSTING THE PROTOCOL FOR PROGESTERONE RECEPTOR (PR). AN AGILENT APPLICATION ENGINEER (AE) VISITED THE SITE THE FOLLOWING DAY AND HELPED TO OPTIMIZE THE PROTOCOL. IT WAS ON (B)(6) 2025 WHILE THE AE WAS ON SITE DOING VERIFICATION EXPERIMENTS, THE CUSTOMER (B)(6) HOSPITAL REPORTED CONFLICTING RESULTS OF THE PR RESULTS FOR 1 PATIENT BETWEEN THIS HOSPITAL AND ANOTHER HOSPITAL. THE INITIAL RUN BY THIS HOSPITAL WAS COMPLETED ON APPROXIMATELY (B)(6) 2025 AND SHOWED POSITIVE PR STAINING. THE PATIENT INDEPENDENTLY WENT TO ANOTHER HOSPITAL AND RECEIVED STAINING RESULTS THAT SHOWED NEGATIVE PR STAINING, THEREBY PRESENTING A POSSIBLE FALSE POSITIVE RESULT. THE INITIAL RUN'S RESULTS BY (B)(6) HOSPITAL WERE NEGATIVE ESTROGEN RECEPTOR (ER) AND POSITIVE PR. (B)(6) HOSPITAL'S STANDARD PROCEDURE STATES THEY NEED TO RE-RUN THE TEST TO RULE OUT / PREVENT FALSE RESULTS FROM BEING RELEASED. THE HOSPITAL RE-RAN THE SAMPLE AND RECEIVED THE SAME RESULTS, NEGATIVE ER AND POSITIVE PR. THE RESULTS WERE PROVIDED TO THE PATIENT. THE PATIENT THEN TOOK THESE RESULTS AND OTHER IMAGE RECORDS PROVIDED BY (B)(6) HOSPITAL TO ANOTHER HOSPITAL. THE OTHER HOSPITAL REVIEWED THE INITIAL RESULTS AND IMAGE RECORDS PROVIDED BY PATIENT AND AGREED THAT THE INITIAL RESULTS WERE NEGATIVE ER AND POSITIVE PR. HOWEVER, THERE WERE SOME DIFFERENT UNDERSTANDINGS BETWEEN THE TWO HOSPITALS WHEN INTERPRETING THE STAINING RESULTS. WHILE (B)(6) HOSPITAL STATED THE STAINING RESULT SHOWED 10% OF NUCLEI WERE STAINED (1% OR HIGHER IS POSITIVE STAINING PER THE IFU) THE OTHER HOSPITAL STATES THE STAINING RESULT SHOWED ONLY 5% OF NUCLEI WERE STAINED. ACCORDING TO THE LIMITED INFORMATION SHARED BY PATIENT, IT WAS KNOWN THAT THE OTHER HOSPITAL RE-RAN THE PATIENT'S TISSUE ON A COMPETITOR PLATFORM AFTERWARDS, WITH A COMPETITOR REAGENT AND RECEIVED NEGATIVE ER AND NEGATIVE PR, I.E. A NEGATIVE RESULT. THIS IS DIFFERENT FROM THE INITIAL TESTING RESULT BY (B)(6) HOSPITAL. THE PATIENT RETURNED TO (B)(6) HOSPITAL TO SHARE THE INFORMATION AND PROVIDE THE TEST RESULTS AND IMAGE RECORDS GENERATED BY THE OTHER HOSPITAL. IT WAS CONFIRMED THE PATIENT DID NOT RECEIVE TREATMENT IN THE INITIAL HOSPITAL. HOWEVER, THE HEALTH STATUS OF THE PATIENT IS UNKNOWN AND THE PATIENT HAS NOT SHARED ANY FURTHER INFORMATION WITH THE HOSPITAL. THE AE FOUND NO ISSUE WITH THE INSTRUMENT NOR ANY ISSUES WITH THE REAGENT. THE AE VERIFIED PROPER STAINING BY USING DIFFERENT BATCH NUMBERS AND OTHER BRANDS OF ANTIBODIES AND THE RESULTS WERE CONSISTENTLY POSITIVE. THE WERE NO PROBLEMS IN STAINING THE EXTERNAL AND INTERNAL CONTROLS AS THEIR RESULTS WERE ALSO CONSISTENTLY POSITIVE. HOWEVER, IT WAS RECOMMENDED TO THE CUSTOMER TO VALIDATE THEIR STAINING PROTOCOL WITH A LARGER SAMPLE, GREATER THAN 10 CASES, TO ENSURE TEST ACCURACY. THE NEGATIVE STAINING RESULT OBTAINED BY THE OTHER HOSPITAL WAS NOT ABLE TO BE REPRODUCED, AND THE IMAGES OF THE NEGATIVE STAINING ARE NOT ABLE TO BE REVIEWED. AS NO ISSUES WERE FOUND WITH ANY AGILENT PRODUCT, AND THE CONTRADICTORY STAINING IS UNABLE TO BE REVIEWED, THE ROOT CAUSE FOR THE EVENT IS UNABLE TO BE DETERMINED. ALTHOUGH THERE IS NO CONCLUSIVE EVIDENCE DIRECTLY LINKING AGILENT'S REAGENT OR INSTRUMENT TO THE ALLEGED INCORRECT DIAGNOSTIC RESULT, OR POTENTIAL SUBSEQUENT INAPPROPRIATE TREATMENT TO THE PATIENT; THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347470 | FLEX MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR CLONE PGR 636 READY-TO-US | REAGENT | MXZ | AGILENT TECHNOLOGIES, INC. | IR068 | 11657531 | 05700573000920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |