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

Catalog Number 08946370190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with the elecsys testosterone ii assay on a cobas e 801 analytical unit.The sample resulted in a testosterone value of 14.8 nmol/l when tested on the e 801 analyzer.The patient was then sent to another hospital where another sample was collected and this sample resulted in a low testosterone value.The complained sample was then repeated using a competitor method, resulting in a testosterone value of 0.94 nmol/l.

Manufacturer Narrative

The serial number of the e 801 analyzer is (b)(6).The competitor method is abbott.The patient sample was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

Calibration and controls were acceptable.The patient sample was provided for investigation.The result obtained by the customer could be reproduced.Investigations of the sample determined that it contains an interfering factor against the ruthenium label of the testosterone assay.A streptavidin interference could be excluded.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product issue.

• 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: 18032047
• MDR Text Key: 326874095
• Report Number: 1823260-2023-03470
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K211685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08946370190
• Device Lot Number: 68938401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• 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: 37 YR
• Patient Sex: Female