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

Catalog Number 05200067190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys testosterone ii assay on a cobas e 411 immunoassay analyzer.It is not known if the result from the e411 analyzer was reported outside of the laboratory.The testosterone value measured on the e 411 analyzer is > 52 nmol/l (reference range = 8.6 - 29.0 nmol/l).Clinicians were expecting a low testosterone value from the patient as hypogonadism was suspected.The e 411 value did not correlate to the patient's clinical picture.This sample was sent to another laboratory for testing on a beckman dxi analyzer, resulting with a value of 37.78 nmol/l (reference range = 8.4 - 28.7 nmol/l).The serial number of the e 411 analyzer is (b)(4).

Manufacturer Narrative

The customer has confirmed that the value from the e411 analyzer was reported outside of the laboratory.

Manufacturer Narrative

Calibration data was within expectations.Quality controls were within range on (b)(6)-2020.A general reagent issue can be excluded as controls recovered within expectations.Performance testing run on the analyzer was within range.Both elecsys and beckman testosterone results show the same clinical picture above expected values.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11177581
• MDR Text Key: 250521088
• Report Number: 1823260-2021-00191
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• PMA/PMN Number: K093421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 05200067190
• Device Lot Number: 488796
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR