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

Catalog Number	08946370190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's cobas 6000 core unit 150 serial number is (b)(6).The customer's cobas e 801 analytical unit serial number is (b)(6).Patient sample 1 - the patient sample was insufficient for investigation.Patient sample 2 and patient sample 4 - the patient samples were received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys estradiol iii assay and elecsys testosterone ii assay results from four patient samples tested on the cobas 6000 core unit 150 (cn vers.) and cobas e 801 analytical unit.This medwatch is for the elecsys testosterone ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys estradiol iii assay.The initial results were not reported outside of the laboratory.The cobas e 601 analyzer results were inconsistent with the patients' clinical statuses.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.
Additional Manufacturer Narrative
Medwatch field b7 other relevant history was updated.The elecsys testosterone ii assay calibration results were acceptable.The qc level 1 was close to the mean; qc level 2 was outside the 3 standard deviation range.The pre-analytical data provided did not indicate any issues.A general reagent issue is not very likely because the qc results are within the specified ranges.Patient sample 2 and patient sample 4 - the patient samples were tested for the presence of an interferent using streptavidin (sa) heterophilic antibody testing (hbt).The test revealed the presence of sa and hbt interferents in the patient sample.The investigation determined that the streptavidin (sa) and heterophilic antibody interferent had caused the event.Elecsys testosterone ii assay product labeling states, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by a suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings." the investigation did not identify a product problem.

• 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: 22008568
• Report Number: 1823260-2025-01473
• Device Sequence Number: 5355653
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 09/30/2025
• Device Catalogue Number: 08946370190
• Device Lot Number: 79495801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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 Age: 6 YR
• Patient Sex: Male