MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 iii assay, and elecsys cortisol ii on a cobas 8000 e 602 module.The sample also had a discrepant result for the elecsys ft4 ii assay when tested on an elecsys analyzer used for investigation.No incorrect results were reported outside of the laboratory.It was not clear if the elecsys analyzer used for investigation was a cobas 8000 e 602 module or if it was a cobas 8000 e 801 module.A clarification has been requested.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4iii assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4ii assay, and refer to the medwatch with patient identifier (b)(6) for information related to the cortisol assay.The sample was initially tested on the customer¿s e 602 analyzer on (b)(6) 2019.The sample was provided for investigation where it was repeated on an elecsys analyzer on 09-aug-2019.The sample was also repeated on an abbott architect analyzer.The serial number of the customer's e 602 analyzer is (b)(4).The serial number of the elecsys analyzer used for investigation is (b)(4).Tsh reagent lot number 402248, with an expiration date of november 2019 was used on this analyzer.

Manufacturer Narrative

The elecsys analyzer used for investigation has been confirmed as a cobas 8000 e 602 module.

Manufacturer Narrative

Upon investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in 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.For diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examinations and other findings.

Manufacturer Narrative

Data was provided for a second sample from the same patient.This sample had discrepant results for tsh, ft3, and ft4iii when tested on the customer's e 602 module.The sample also had a discrepant result for the ft4ii assay when tested the e 602 analyzer used for investigation.Refer to the attachment for all data from this sample.The sample was initially tested on the customer's e 602 analyzer on (b)(6) 2019.The sample was repeated on an architect analyzer.The sample was also provided for investigation, where it was tested on the second e 602 analyzer on (b)(6) 2019.No incorrect results were reported outside of the laboratory.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8961149
• MDR Text Key: 212311803
• Report Number: 1823260-2019-03209
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1