MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ESTRADIOL III ASSAY; RADIOIMMUNOASSY, ESTRADIOL

Catalog Number	06656021190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 601 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with the elecsys estradiol iii assay on a cobas 6000 e 601 analyzer.The first sample initially resulted in an estradiol value of > 3000 pg/ml with a data flag.The sample was automatically repeated with dilution, resulting in a value of 2249 pg/ml.The second sample initially resulted in an estradiol value of > 3000 pg/ml with a data flag.The sample was automatically repeated with dilution, resulting in a value of 2360 pg/ml.The third sample initially resulted in an estradiol value of > 3000 pg/ml with a data flag.The sample was automatically repeated with dilution, resulting in a value of 2397 pg/ml.The fourth sample initially resulted in an estradiol value of > 3000 pg/ml with a data flag.The sample was automatically repeated with dilution, resulting in a value of 2601 pg/ml.
Additional Manufacturer Narrative
Correction to patient 3 medication: incorrect= "temco (once daily - patient 3)" correct = fernco (once daily - patient 3).All patients are female.Medwatch fields a3 and d10 have been updated.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue is not evident.A review of alarm trace data showed multiple abnormal aspiration alarms near the time of the event.The investigation could not identify a product problem.The cause of the event could not be determined.Patients in ivf treatment are not "healthy" with respect to their hormone status; this is due to 1) hormonal disorders causing conception to fail (multiply), and due to 2) the hormone stimulation treatment.This particular patient status and the patient treatment causes unidentifiable and even patient-specific metabolites, that interact with the detection system of e2 iii and can cause cross-reactivity detection.

• Brand Name: ELECSYS ESTRADIOL III ASSAY
• Common Device Name: RADIOIMMUNOASSY, ESTRADIOL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23042566
• Report Number: 1823260-2025-02861
• Device Sequence Number: 10096198
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K965109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 06656021190
• Device Lot Number: 84459400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 10/16/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTIN (ONCE DAILY - PATIENT 4).; D3K2 (ONCE DAILY - PATIENT 3).; DRENAMIN (TWICE DAILY - PATIENT 3).; ECHINACEA (ONCE DAILY - PATIENT 3).; FERNCO (ONCE DAILY - PATIENT 3).; GOTO KOLA (ONCE DAILY - PATIENT 3).; LEVOTHYROXINE (ONCE DAILY - PATIENT 1).; MAGNESIUM (ONCE DAILY - PATIENT 3).; MESALAMINE (4 TABLETS - PATIENT 4).; NATURE MADE PRENATAL (ONCE DAILY - PATIENT 2).; OVASITOL (2 SCOOPS DAILY - PATIENT 2).; PNEUMOTROPHIN (TWICE DAILY - PATIENT 3).; PRENATALS (ONCE DAILY - PATIENT 1).; PROBIOTICS (ONCE DAILY - PATIENT 4).; TEMCO (ONCE DAILY - PATIENT 3).; UTROPHIN (ONCE DAILY - PATIENT 3).; VITAMIN D (2 TABLETS DAILY - PATIENT 4).
• Patient Age: 33 YR
• Patient Sex: Female