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

Model Number	08946370190
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	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with the elecsys testosterone ii assay on a cobas e 801 analytical unit.The sample resulted in a testosterone value of 14.8 nmol/l when tested on the e 801 analyzer.The patient was then sent to another hospital where another sample was collected and this sample resulted in a low testosterone value.The complained sample was then repeated using a competitor method, resulting in a testosterone value of 0.94 nmol/l.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The competitor method is abbott.The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.The patient sample was provided for investigation.The result obtained by the customer could be reproduced.Investigations of the sample determined that it contains an interfering factor against the ruthenium label of the testosterone assay.A streptavidin interference could be excluded.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product issue.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18032047
• Report Number: 1823260-2023-03470
• Device Sequence Number: 5914172
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 08/29/2024

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: 04/30/2024
• Device Model Number: 08946370190
• Device Catalogue Number: 08946370190
• Device Lot Number: 68938401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 08/29/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/09/2024; 08/29/2024
• 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: 37 YR
• Patient Sex: Female