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

Model Number	08946353190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable testosterone g2 elecsys results from the cobas e411 rack analyzer.Patient 1 initial result was >1500 ng/dl and the repeat results were 69.83 ng/dl and 46.45 ng/dl.The repeat results on another analyzer were 28.62 ng/dl and 33.47 ng/dl.Patient 2 initial result was 177.5 ng/dl and the repeat results were 46.47 ng/dl and 109.8 ng/dl.The repeat results on another analyzer were 38.24 ng/dl and 39.83 ng/dl.The results from the other analyzer were believed correct.
Additional Manufacturer Narrative
The customer took samples of dust in the laboratory and also swabbed the area around the instrument, as well as sample/reagent probe.The samples were tested at a nearby facility and each one resulted as greater than the measuring range for testosterone.The field service engineer determined the cause of the event was the testosterone contamination, likely coming from the hyase product used in the ivf lab on site.He replaced the sample/reagent probe and pressure sensor tubing.He performed sample/reagent probe, sipper, and gripper adjustments.He replaced the measuring cell and syringe assembly and ran performance testing that passed.As the qc recovery was within the acceptable range, there was no indication of a performance issue with the reagent.
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: 18165696
• Report Number: 1823260-2023-03661
• Device Sequence Number: 17768062
• Product Code: CDZ
• UDI-Device Identifier: 07613336170557
• UDI-Public: 07613336170557
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: 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 Model Number: 08946353190
• Device Catalogue Number: 08946353190
• Device Lot Number: 688765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 08/29/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/01/2023; 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1: DOXYCYCLINE HYCLATE.; PATIENT 1: PROVERA.
• Patient Age: 34 YR
• Patient Sex: Female