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

Catalog Number 07027915190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.

Event Description

The initial reporter complained of discrepant high results for 1 patient tested for elecsys testosterone ii (testosterone ii) on a cobas e 801 module compared to the beckman method.The result from the e801 module was > 52 nmol/l.The sample was repeated on the e801 module and the result was the same.The sample was tested by the beckman method and the result was 11.11 nmol/l.The customer suspects an interference affecting the roche results as the patient does not have a condition that would cause elevated testosterone results.The e801 module serial number is (b)(4).

Manufacturer Narrative

The patient sample was sent to an external laboratory where the testosterone result from the abbott method was 69.14 nmol/l.This result is comparable to the roche results.A product problem was not identified.

Manufacturer Narrative

On (b)(6) 2020 the patient had a testosterone ii result on the e801 module of > 52 nmol/l.On (b)(6) 2020 04-mar-2020 the patient had a testosterone ii result on the e801 module of 37.3 nmol/l.The patient was not taking hyperthyroidism medication at the time of these tests.Section d11 was updated.The sample submitted for investigation is undergoing further testing.

Manufacturer Narrative

The sample was received for investigation and tested on a cobas e411 and a cobas e801; the customer's results were reproduced: e411: 65.23 nmol/l.E801: 61.25 nmol/l.The sample was tested further to investigate the presence of an interfering factor.An interfering factor was not identified.Based on the investigation results, a general reagent issue was not observed.The investigation did 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: 9547182
• MDR Text Key: 217690607
• Report Number: 1823260-2020-00030
• 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,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 07027915190
• Device Lot Number: 353224
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN.
• Patient Age: 57 YR