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 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable results for multiple tests for 1 patient tested on a cobas 8000 e 801 module compared to an advia centauro.From the data provided, a reportable malfunction was provided for elecsys ft3 iii, elecsys prolactin assay, elecsys t3, elecsys t4 assay, elecsys testosterone ii assay, and elecsys estradiol iii assay.The customer suspect there is an interference affecting the patient sample.This medwatch will cover the testosterone assay.Patient identifiers for information related to each other affected assay: (b)(6).The discrepant results are highlighted.It was unknown if the erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.

Manufacturer Narrative

A sample was provided for investigation.Due to low sample volume (~200 ul) only limited testing could be performed.The results of the testing are consistent with an antibody against a component of the reagent.This interring factor is addressed in the product labeling.

Manufacturer Narrative

Another aliquot of the patient sample was provided for further investigation.The results obtained by the customer were reproduced.An interferent against a component of the reagent was confirmed.This interference is covered in product labeling.From the information and data provided, a general reagent issue most likely can be excluded.

• 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: 8059173
• MDR Text Key: 129046813
• Report Number: 1823260-2018-04174
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 04015630939817
• UDI-Public: 04015630939817
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027915190
• Device Lot Number: 326953
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR