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

Model Number TSH

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for 4 patients tested on a cobas 8000 e 801 module.From the data provided, 3 patients had discrepant results for elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii and 1 patient had discrepant results for ft4 iii and ft3 iii.The customer's cobas e801 data was compared to an investigation site's cobas 8000 e 801 module, cobas 8000 e 602 module, cobas e 411 immunoassay analyzer, and a centaur system.This medwatch with cover tsh.Refer to medwatch with patient identifier of (b)(6) for information on the ft4 iii results and to medwatch with patient identifier of (b)(6)for information on the ft3 iii results.It was unknown if the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was requested but was not provided.The serial number for the cobas e602 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 391521 with an expiration date of 29-feb-2020.The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019.The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019.The serial number for the cobas e411 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 378826 with an expiration date of 31-aug-2019.The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019.The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019.The serial number for the cobas e801 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 380330 with an expiration date of 31-dec-2019.The ft3 iii reagent lot used on this analyzer was 348359 with an expiration date of 31-oct-2019.The tsh reagent lot used on this analyzer was 386646 with an expiration date of 31-may-2020.

Manufacturer Narrative

Upon investigation of the patient sample, an interferent against a 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 examination and other findings.

• 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: 8892519
• MDR Text Key: 175216849
• Report Number: 1823260-2019-02981
• 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
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1