MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; TESTOSTERONE ASSAY

Catalog Number	08946353190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys testosterone ii assay result from the cobas 6000 e601 module.The affected patient also had questionable estradiol results.This medwatch will apply to the elecsys testosterone ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys estradiol iii assay.The initial result was 1061 ng/dl, and the 1st repeat result was 1073 ng/dl.A 2nd repeat result from the same initial draw, but a new sample tube was 1113 ng/dl.A result from a new sample from the same patient was 192.3 ng/dl.The result of 192.3 ng/dl was deemed to be correct.The initial result was questioned by the care provider as it did not match the patient's clinical picture.They ordered a new sample to be drawn from the patient.
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
A field service engineer (fse) checked fluidics and ran a precision check.The precision check results were in range.The investigation was unable to determine a direct root cause.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Common Device Name: TESTOSTERONE ASSAY
• 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: 22080015
• Report Number: 1823260-2025-01593
• Device Sequence Number: 9363646
• Product Code: CDZ
• UDI-Device Identifier: 07613336170557
• UDI-Public: 07613336170557
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K211685
• 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
• Report Date (Section B): 06/06/2025

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: 08/31/2025
• Device Catalogue Number: 08946353190
• Device Lot Number: 78689801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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: ADRENAMED GL50.; LIPID FACTOR.; METHYL FOLATE.
• Patient Age: 40 YR
• Patient Sex: Female