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 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) verified probe fluidics and performed a hardware test and a 21 cup precision test successfully.The fse also noticed that the collected sample tube contained fibrin.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys testosterone ii assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.On (b)(6) 2024, the initial testosterone result was >1500 ng/dl with flag.The doctor questioned the result and the customer repeated the sample.On (b)(6) 2024, the sample was repeated and the repeat results were 720.4 ng/dl and 722.8 ng/dl.

• 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: 18942817
• MDR Text Key: 338446921
• Report Number: 1823260-2024-00825
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 74053001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Male