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

Catalog Number 08946370190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

The initial reporter stated they have been having ongoing issues with an unspecified number of patient samples tested with elecsys testosterone ii on the customer's cobas e 801 module (serial number (b)(6) ) and up to three e 801 analyzers at a second site (serial numbers (b)(6) ).The reporter stated the issue occurs rarely, but has occurred often enough to question whether the affected samples may contain an interfering substance.Samples are collected from patients and aliquots of each sample are tested with the same roche testosterone assay at the customer site and at the second site.The reporter stated for example, a patient sample aliquot tested at the customer site will result in a testosterone value of 10 ng/ml, and the aliquot sent to the second site will result in a value of 100 ng/ml.When the aliquot from the second site is then tested at the customer site, it results in a value of 100 ng/ml and when the customer aliquot is sent to the second site, it results in a value of 10 ng/ml.The customer provided sample data for twenty-three patients.Refer to the attachment for all patient data.The samples were tested on the customer's e 801 analyzer and then repeated at the second site on one of the three e 801 analyzers used there.It is not known which specific e 801 analyzer was used to test each sample at the second site.Some samples were also tested using an lcms method at both the customer site and the second site.The following additional testosterone values were provided, but it is not known which patient this data corresponds to or if it is data from an additional patient: customer site testosterone = 14.5 ng/ml, customer site testosterone (lcms method) = 15.8 ng/ml, second site testosterone = 15.6 ng/ml.A clarification has been requested for this data.

Manufacturer Narrative

The following information was provided in the initial medwatch: "the following additional testosterone values were provided, but it is not known which patient this data corresponds to or if it is data from an additional patient: customer site testosterone = 14.5 ng/ml, customer site testosterone (lcms method) = 15.8 ng/ml, second site testosterone = 15.6 ng/ml.A clarification has been requested for this data." the customer clarified that this data was for a patient sample that was used as a control to determine baseline bias between the methods.The sample showed close agreement for the roche results at both sites and the lcms results.The following testosterone reagent lots were used: on e 801 serial number (b)(6), reagent lot 620937 was used from (b)(6)2022 until (b)(6)2023.On e 801 serial number (b)(6), reagent lots 620937 and 651126 were both used on (b)(6) 2023.From (b)(6) 2023 until (b)(6) 2023, reagent lot 620937 was used.On e 801 serial number (b)(6), reagent lot 620931 was in use from (b)(6) 2022 until (b)(6)2022.Reagent lot 651126 was in use from (b)(6) 2022 until (b)(6) 2023.Reagent lot 620937 was in use from (b)(6) 2023 until (b)(6) 2023.

Manufacturer Narrative

Calibration and controls recovered within expected ranges.The alarm trace showed no abnormalities.The cross-reaction of androtardyl (testosterone enanthate) with elecsys testosterone gen.2 is negligible (< 2.5%).A general product problem could be excluded as the provided quality control recovery was within expectations.Sample interference and tube interference can be ruled out because the elecsys testosterone test would measure the same at all locations.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect sample handling.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: TESTOSTERONE ASSAY
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16854926
• MDR Text Key: 314415840
• Report Number: 1823260-2023-01485
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K211685
• 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,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08946370190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• 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
• Treatment: REFER TO THE ATTACHMENT FOR PATIENT MEDICATION