MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Model Number ANTI-TSHR

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter stated they received discrepant thyroid results for three samples from the same patient tested on a cobas 8000 e 602 module.The first sample (dated (b)(6) 2019) had discrepant results for the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay.The incorrect results from this sample were reported outside of the laboratory to the patient.This sample was repeated on a siemens analyzer.The second sample (dated (b)(6) 2019) had discrepant ft3 and ft4 results.No incorrect results from this sample were reported outside of the laboratory.This sample was repeated on an ortho vitros analyzer.The third sample (dated (b)(6) 2019) had discrepant results for the elecsys anti-tshr immunoassay.It was asked, but it is not known if any incorrect results from this sample were reported outside of the laboratory.This sample was repeated on an ortho vitros analyzer.This medwatch will apply to the anti-tshr assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.Refer to all patient data.The serial number of the reporter's e 602 analyzer is (b)(4).

Manufacturer Narrative

It has been clarified that no incorrect results were reported outside of the laboratory for the third sample dated (b)(6) 2019.

Manufacturer Narrative

Medwatch field model #, serial #, expiration date, catalog #, lot #, other #, udi # has been updated.

Manufacturer Narrative

Upon further investigation of the patient sample, the values measured at the customer site could be reproduced.It was determined that the sample contains an interfering factor against the streptavidin component of the anti-tshr assay.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: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9178514
• MDR Text Key: 217308371
• Report Number: 1823260-2019-03656
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANTI-TSHR
• Device Catalogue Number: 08496609190
• Device Lot Number: 406920
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 09/24/2019; 09/24/2019
• Supplement Dates FDA Received: 10/11/2019; 11/21/2019; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TOPAZOLE.