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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received questionable results on a cobas 8000 e 602 module for a sixth sample collected from the same patient previously reported in the following mfg report numbers: 1823260-2021-03003, 1823260-2021-03004, 1823260-2021-03005, and 1823260-2021-03006.This sixth sample had questionable results for the following assays: the elecsys ft4 iii assay, elecsys cortisol ii, the elecsys estradiol iii assay, and the elecsys testosterone ii assay.No units of measure were provided for the estradiol or testosterone results.The sample results were reported outside of the laboratory.This medwatch will apply to the testosterone assay.Please refer to the medwatch with mfg report number 1823260-2021-03003 for information related to the ft4 assay.Please refer to the medwatch with mfg report number 1823260-2021-03006 for information related to cortisol.Please refer to the medwatch with patient identifier (b)(6) for information related to the estradiol assay.This sixth sample resulted in the following values when tested on the e 602 analyzer: ft4 = 56.19 pmol/l.Cortisol = 933 nmol/l.Estradiol = 485.5.Testosterone = 4.5.This sixth sample resulted in the following values when tested on a siemens atelica analyzer at a second site: ft4 = 17.4 pmol/l.Cortisol = 558.0 nmol/l.Estradiol = 55.Testosterone = 0.73.The serial number of the e 602 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations were able to reproduce the results obtained by the customer.Further investigations of the sample determined that it contains an interfering factor against the streptavidin component of the ft3, ft4, tsh, cortisol, estradiol, and testosterone assays.This interfering factor leads to falsely elevated ft3, ft4, cortisol, estradiol, and testosterone results and leads to decreased results for tsh.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12773844
• MDR Text Key: 280525394
• Report Number: 1823260-2021-03273
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: MU
• 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
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female