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

Catalog Number	05200067160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas e602 module serial number was (b)(6).Qc was performed and was acceptable.Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys testosterone ii assay (testosterone ii) on a cobas 8000 cobas e602 analyzer when compared to the liquid chromatography¿mass spectrometry (lcms/ms) method at a different facility.Initial result: 196 ng/dl (e602 module).Repeat result: 308 ng/dl (lcms/ms method).The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The investigation noted the qc to be within 2 standard deviations (sd) on the date of the event.The investigation reviewed the instrument information trace.Film detection, several abnormal aspiration and a sample short alarms were noted on the date of the event.These may be indicators of poor sample quality.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• 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: 17637655
• Report Number: 1823260-2023-02791
• Device Sequence Number: 12382386
• Product Code: CDZ
• UDI-Device Identifier: 04015630939312
• UDI-Public: 04015630939312
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 05200067160
• Device Lot Number: 688765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/27/2023
• 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 Age: 46 YR
• Patient Sex: Male