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

Catalog Number ASKU

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

The patient sample was returned for investigation.Investigations are ongoing.

Event Description

The initial reporter stated they received questionable results for one patient sample tested with the elecsys tsh ver.2 assay, ft4, ft3, elecsys cortisol ii, elecsys testosterone ii assay, and elecsys dhea-s on a cobas e 411 immunoassay analyzer.The results measured on the e411 analyzer did not compare to results obtained with competitor methods.The results from the e411 analyzer were reported outside of the laboratory.The specific ft3 and ft4 assays used are unknown.This medwatch will apply to the testosterone assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the cortisol assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the dhea-s assay.The sample was initially tested on the customer's e411 analyzer.The sample was then sent to a second site, where it was tested on a beckman coulter instrument and discrepancies were observed.The sample was treated with a heterophilic blocking tube and ft3 and ft4 testing was repeated on the beckman analyzer with no improvement in recovery.The sample was repeated again on the siemens atellica and abbott architect platforms.The reporter stated that the patient was recently tested again on the e411 analyzer and the same pattern was found.The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation and preliminary investigations were able to duplicate the results obtained by the customer.No interfering factor against the streptavidin component of the affected assays could be detected in the sample.

Manufacturer Narrative

Further investigations of the sample determined that it contains an interfering factor against the streptavidin component of the assay.Immunoglobulin concentrations were measured in the sample and a highly elevated concentration of igm could be determined, which leads to further unspecific interference in the assay.These interferents would affect recovery of all elecsys assays.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: 13563455
• MDR Text Key: 292580378
• Report Number: 1823260-2022-00435
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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?: Yes
• Date Manufacturer Received: 03/22/2022
• 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: 70 YR
• Patient Sex: Female