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

Catalog Number	08946353190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys testosterone ii assay (testosterone ii) on a cobas 8000 e 602 module.The initial result was 52.05 nmol/l with a data flag.This result was reported outside of the laboratory.The physician questioned the result as it did not correspond to the patient's clinical picture and requested repeat testing.The sample was repeated twice with results of 8.21 nmol/l and 7.91 nmol/l.The e602 module serial number was (b)(6).
Additional Manufacturer Narrative
A specific root cause could not be determined.A general reagent problem could be excluded because this was an isolated non-reproducible event.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17195029
• Report Number: 1823260-2023-02085
• Device Sequence Number: 20657957
• Product Code: CDZ
• UDI-Device Identifier: 07613336170557
• UDI-Public: 07613336170557
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/17/2023

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 Catalogue Number: 08946353190
• Device Lot Number: 68876501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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
• Patient Sex: Unknown