ALINITY I ESTRADIOL REAGENT KIT
Report
- Report Number
- 3005094123-2024-00323
- Event Type
- Injury
- Date Received
- June 17, 2024
- Date of Event
- April 30, 2023
- Report Date
- August 29, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- CHP
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED WITHIN THE ARTICLE, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION WITHIN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. THE TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. AN ADDITIONAL SUB SEARCH FOR SIMILAR COMPLAINTS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A PRODUCT QUALITY HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. PER PRODUCT LABELING, SAMPLES FROM PATIENTS ADMINISTERED MEDICATIONS WHICH INHIBIT TUMOUR CELL PROLIFERATION (E.G. CDK 4/6 INHIBITORS) MAY BE SUBJECT TO INTERFERENCE/CROSS REACTIVITY WITH THE ALINITY I ESTRADIOL ASSAY. IN ADDITION, DRUGS WHICH INTERFERE WITH OR ACTIVATE PRODUCTION OF STEROID HORMONES (E.G. AROMATASE INHIBITORS) MAY ALSO INTERFERE OR CROSS REACT WITH THE ALINITY I ESTRADIOL ASSAY. IN SUCH CASES, AN ALTERNATE METHOD SUCH AS CHROMATOGRAPHY SHOULD BE USED. IN THIS CASE, THE ASSAY SHOULD NOT HAVE TO BEEN USED TO TEST ESTRADIOL LEVELS OF PATIENTS UNDERGOING TREATMENT WITH ABEMACICLIB AS IT IS A KNOWN INTERFERENT. BASED ON THE INVESTIGATION THE ALINITY I ESTRADIOL IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ESTRADIOL ASSAY WAS IDENTIFIED.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
A CONFERENCE ABSTRACT BY ALAIN KESSLER, RIMA PATEL, EMILY GALLAGHER, TIANXIANG SHENG, DAMODARA RAO MENDU, AMY TIERSTEN, PAULA KLEIN, AARTI BHARDWAJ, ANUPAMA GOEL, JOSEPH SPARANO, THERESA SHAO, JULIE FASANO, ¿CONCERNING DISCREPANCIES IN ESTRADIOL LEVELS IN PREMENOPAUSAL WOMEN RECEIVING ABEMACICLIB AND OVARIAN FUNCTION SUPPRESSION¿, CANCER RESEARCH, SUPPL. SUPPLEMENT 84.9 AMERICAN ASSOCIATION FOR CANCER RESEARCH INC. (MAY 2024), DOCUMENTED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS DUE TO AN INTERFERENCE OF ABEMACICLIB. THE CONFERENCE ABSTRACT WAS A RETROSPECTIVE REVIEW OF 22 PREMENOPAUSAL WOMEN WITH EARLYSTAGE HR+ BREAST CANCER TREATED WITH ADJUVANT OVARIAN FUNCTION SUPPRESSION (OFS) AND ABEMACICLIB FROM OCTOBER 2021 TO APRIL 2023 WHO HAD AT LEAST 1 CMIA ESTRADIOL LEVEL DRAWN DURING ABEMACICLIB THERAPY. THERE WERE 2 PATIENTS IDENTIFIED DURING THE STUDY WHO UNDERWENT BILATERAL SALPINGO-OOPHORECTOMY (BSO) DUE TO PERSISTENTLY ELEVATED CMIA ESTRADIOL LEVELS. FOLLOWING SURGERY, THESE PATIENTS HAD PERSISTENTLY ELEVATED CMIA ESTRADIOL BUT LOW LC-MS/MS ESTRADIOL. THE CONFERENCE ABSTRACT DID NOT INCLUDE SPECIFIC PATIENT INFORMATION OR TREATMENT DOSAGE INFORMATION.
A CONFERENCE ABSTRACT BY ALAIN KESSLER, RIMA PATEL, EMILY GALLAGHER, TIANXIANG SHENG, DAMODARA RAO MENDU, AMY TIERSTEN, PAULA KLEIN, AARTI BHARDWAJ, ANUPAMA GOEL, JOSEPH SPARANO, THERESA SHAO, JULIE FASANO, ¿CONCERNING DISCREPANCIES IN ESTRADIOL LEVELS IN PREMENOPAUSAL WOMEN RECEIVING ABEMACICLIB AND OVARIAN FUNCTION SUPPRESSION¿, CANCER RESEARCH, SUPPL. SUPPLEMENT 84.9 AMERICAN ASSOCIATION FOR CANCER RESEARCH INC. (MAY 2024), DOCUMENTED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS DUE TO AN INTERFERENCE OF ABEMACICLIB. THE CONFERENCE ABSTRACT WAS A RETROSPECTIVE REVIEW OF 22 PREMENOPAUSAL WOMEN WITH EARLYSTAGE HR+ BREAST CANCER TREATED WITH ADJUVANT OVARIAN FUNCTION SUPPRESSION (OFS) AND ABEMACICLIB FROM OCTOBER 2021 TO APRIL 2023 WHO HAD AT LEAST 1 CMIA ESTRADIOL LEVEL DRAWN DURING ABEMACICLIB THERAPY. THERE WERE 2 PATIENTS IDENTIFIED DURING THE STUDY WHO UNDERWENT BILATERAL SALPINGO-OOPHORECTOMY (BSO) DUE TO PERSISTENTLY ELEVATED CMIA ESTRADIOL LEVELS. FOLLOWING SURGERY, THESE PATIENTS HAD PERSISTENTLY ELEVATED CMIA ESTRADIOL BUT LOW LC-MS/MS ESTRADIOL. THE CONFERENCE ABSTRACT DID NOT INCLUDE SPECIFIC PATIENT INFORMATION OR TREATMENT DOSAGE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1688116 | ALINITY I ESTRADIOL REAGENT KIT | RADIOIMMUNOASSAY, ESTRADIOL | CHP | ABBOTT IRELAND DIAGNOSTICS DIVISION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability | ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWN01| ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWN01 |