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 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for a total of 11 patient samples tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect values were reported outside of the laboratory.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 and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019.The samples were repeated on a centuar analyzer.The samples were also provided for investigation where they were tested using a cobas 6000 e 601 module and a cobas e 411 immunoassay analyzer on (b)(6) 2019 and a second e 801 analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 386646, with an expiration date of 31-may-2020 was used on this analyzer.The serial number of the e 601 analyzer used for investigation is (b)(4).Tsh reagent lot number 373386, with an expiration date of 30-jun-2019 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Tsh reagent lot number 373386, with an expiration date of 30-jun-2019 was used on this analyzer.

Manufacturer Narrative

The investigation determined the following for samples (b)(6).Assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.The investigation determined the following for samples (b)(6).The investigation could not identify a product problem.The cause of the event could not be determined.The investigation determined the following for sample (b)(6).Further investigations of the patient sample determined that it contained an interferent to a component of the ft3 assay.This limitation is covered in product labeling.

• 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: 8703331
• MDR Text Key: 148171530
• Report Number: 1823260-2019-02193
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1