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	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results of 1 patient's serum sample tested with elecsys testosterone g2 (testosterone ii) assay on a cobas e801 immunoassay analyzer when compared to liquid chromatography mass spectrometry (lc/ms) methodology.Initial result: 4.33 nmol/l.1st repeat result: 4.38 nmol/l (repeated on e801).2nd repeat result: 0.3 nmol/l (tested with lc/ms - referral laboratory).3rd repeat result: 0.39 nmol/l (repeated with lc/ms).4th repeat result: 1.01 nmol/l (tested on beckman coulter).
Additional Manufacturer Narrative
The testosterone reagent expiration date was not provided.The cobas e801 module serial number was (b)(6).The calibration and qc prior to the event were acceptable.The alarm trace showed multiple alarms including sample clot detection alarm, abnormal aspiration (sample probe) alarms, and incubation water short alarm.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 was updated.The sample was not provided for investigation.Calibration was acceptable.The alarm trace showed multiple alarms including a sample foam detection alarm.A general reagent issue can be excluded because qc was acceptable prior to the event.The investigation did not identify a product problem.The cause of the event could not be determined.
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: 18336075
• Report Number: 1823260-2023-04042
• Device Sequence Number: 20518396
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: 689384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 08/29/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/28/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MIRTAZAPINE; PROPRANOLOL
• Patient Age: 24 YR
• Patient Sex: Female