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

Catalog Number 05200067190

Device Problem High Test Results (2457)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys testosterone ii assay results for 1 patient on a cobas e 602 module compared to a beckman analyzer.This medwatch will cover testosterone.Refer to medwatch with a1 patient identifier (b)(6) for information on the estradiol results.The initial testosterone result was 10.84 nmol/l.The sample was repeated the next day on a beckman analyzer and the testosterone result was <0.35 nmol/l.The reference ranges for each assay were not provided.

Manufacturer Narrative

The analyzer serial number is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The patient sample was requested for investigation but was not available.The recovery data provided was acceptable.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II
• Type of Device: 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: 17961257
• MDR Text Key: 326024283
• Report Number: 1823260-2023-03340
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K093421
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05200067190
• Device Lot Number: 713404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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
• Patient Age: 11 YR
• Patient Sex: Male