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

Catalog Number 08946353190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).The investigation is ongoing.

Event 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.

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.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: 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
• MDR Text Key: 328512562
• Report Number: 1823260-2023-03661
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 07613336170557
• UDI-Public: 07613336170557
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K211685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08946353190
• Device Lot Number: 688765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 1: DOXYCYCLINE HYCLATE.; PATIENT 1: PROVERA.
• Patient Age: 34 YR
• Patient Sex: Female