MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II; RADIOIMMUNOASSAY, TESTOSTERONE

Catalog Number	07027915190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).The samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tpo, elecsys anti-tg, elecsys anti-tshr, and elecsys testosterone ii results for 1 patient on a cobas e 801 analytical unit.This medwatch covers the alleged results for the elecsys testosterone ii assay.Please refer to medwatch with a1 - patient identifier = (b)(6) for the alleged elecsys anti-tg assay results, medwatch with a1 - patient identifier = (b)(6) for the alleged elecsys anti-tshr assay results, and medwatch with a1 - patient identifier = (b)(6) for the alleged elecsys anti-tpo assay results.Refer to the highlighted section of attachment(b)(6) for patient results.The samples were repeated due to the results not matching the clinical status of the patient.
Additional Manufacturer Narrative
The patient's sample was tested.A complex interfering factor (against sa) affecting different immunological components of the assays was found in the patient sample during the investigation.Per product labeling: "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 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
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONE
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20146076
• Report Number: 1823260-2024-02559
• Device Sequence Number: 11824339
• Product Code: CDZ
• UDI-Device Identifier: 04015630939817
• UDI-Public: 04015630939817
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K093421
• 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): 01/14/2025

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 Catalogue Number: 07027915190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/14/2025
• 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: CORTANCYL; LEVOTHYROX; NEOMERCAZOLE
• Patient Sex: Unknown