ALINITY I ESTRADIOL REAGENT KIT
Report
- Report Number
- 3005094123-2024-00505
- Event Type
- Injury
- Date Received
- September 30, 2024
- Date of Event
- September 1, 2021
- Report Date
- November 4, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- CHP
- UDI-DI
- 00380740129910
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
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. 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.
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS ON A BREAST CANCER PATIENT. THE PATIENT UNDERWENT ADJUVANT TREATMENT FOR BREAST CANCER INCLUDING SUPPRESSION OF OVARIAN FUNCTION. THE LAB TESTING CONSISTENTLY GENERATED AN ESTRADIOL RESULT OF ABOUT 100 PG/ML, SUGGESTING THE TREATMENT WAS NOT EFFECTIVE. THE PATIENT UNDERWENT SURGERY TO REMOVE HER OVARIES TO ACHIEVE THE LOW ESTRADIOL LEVELS. THE MASS SPECTROMETRY ESTRADIOL LEVELS SHOWED A DISCREPANCY BETWEEN THE ALINITY I ESTRADIOL LEVELS. UPDATE: ON (B)(6) 2024, ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER STATES THAT THE FIRST TIME THE PATIENT GENERATED ESTRADIOL RESULTS WAS IN 2021. THE MOST RECENT ESTRADIOL RESULTS WERE IN 2023 ((B)(6), RUN ON (B)(6) 2023 AND (B)(6) RUN ON (B)(6) 2023). THE RESULTS WERE CONSISTENT WITH THE 2023 DATA. HOWEVER, THE CUSTOMER COULD NOT PROVIDE ACTUAL NUMERICAL VALUES FOR THESE DATES OF TESTING. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER ADDITIONAL INFORMATION. THERE WAS NO FURTHER ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS ON A BREAST CANCER PATIENT. THE PATIENT UNDERWENT ADJUVANT TREATMENT FOR BREAST CANCER INCLUDING SUPPRESSION OF OVARIAN FUNCTION. THE LAB TESTING CONSISTENTLY GENERATED AN ESTRADIOL RESULT OF ABOUT 100 PG/ML, SUGGESTING THE TREATMENT WAS NOT EFFECTIVE. THE PATIENT UNDERWENT SURGERY TO REMOVE HER OVARIES TO ACHIEVE THE LOW ESTRADIOL LEVELS. THE MASS SPECTROMETRY ESTRADIOL LEVELS SHOWED A DISCREPANCY BETWEEN THE ALINITY I ESTRADIOL LEVELS. UPDATE: ON (B)(6) 2024, ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER STATES THAT THE FIRST TIME THE PATIENT GENERATED ESTRADIOL RESULTS WAS IN 2021. THE MOST RECENT ESTRADIOL RESULTS WERE IN 2023 ((B)(6), RUN ON (B)(6) 2023 AND (B)(6) RUN ON (B)(6) 2023). THE RESULTS WERE CONSISTENT WITH THE 2023 DATA. HOWEVER, THE CUSTOMER COULD NOT PROVIDE ACTUAL NUMERICAL VALUES FOR THESE DATES OF TESTING. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER ADDITIONAL INFORMATION. THERE WAS NO FURTHER ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45360 | ALINITY I ESTRADIOL REAGENT KIT | RADIOIMMUNOASSAY, ESTRADIOL | CHP | ABBOTT IRELAND DIAGNOSTICS DIVISION | 00380740129910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |