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

Catalog Number	06656021190
Medical Device Problem Codes	Unable to Obtain Readings (1516); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (disk system) serial number is (b)(6).The customer does not wear gloves when handling the module and uses a hormone hand creme with estradiol.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys estradiol iii assay results from one patient sample tested on the cobas e 411 analyzer (disk system).On (b)(6) 2025: the initial result with the patient sample in the original tube was <0.5 pg/ml.On (b)(6) 2025: the first repeat result with the patient sample in the original tube was 78.77 pg/ml.On (b)(6) 2025: the second repeat result with the patient sample in a hitachi cup was 22.51 pg/ml.The third repeat result with the patient sample in the original tube was 8.07 pg/ml.The fourth repeat result with the patient sample in a hitachi cup was 22.0 pg/ml.The doctor questioned the initial result, prompting the patient's sample to be rerun.
Additional Manufacturer Narrative
The investigation reviewed the calibration and qc data; the results were within the specified ranges.A general reagent problem was not present because the qcs before the event were within the specified ranges.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation determined the event was due to a preanalytic issue at the customer site (contamination of instrument/surroundings/patient sample with estradiol by the laboratory technologist who uses an estradiol-containing hand cream and did not wear gloves).Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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: 22370265
• Report Number: 1823260-2025-01997
• Device Sequence Number: 18149032
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 844594
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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
• Patient Sex: Unknown