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

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys tsh assay on a cobas 8000 e 801 module and a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation.The second sample also had discrepant results for the elecsys ft4 iii assay when tested on the same analyzers.This medwatch will cover the tsh assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay.Refer to the attachment for all patient data.Values highlighted in yellow are discrepant.The samples were initially tested on the e 801 analyzer at the customer site on (b)(6) 2020.The samples were repeated on a centaur analyzer.The samples were also provided for investigation where they were tested on a second e 801 analyzer, an e 602 analyzer, and an e411 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Tsh reagent lot number 429091, with an expiration date of 30-apr-2020 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Tsh reagent lot number 429091, with an expiration date of 30-apr-2020 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 416233, with an expiration date of 31-oct-2020 was used on this analyzer.

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.All results were within their assay specific reference ranges.

• 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: 9859660
• MDR Text Key: 220802925
• Report Number: 1823260-2020-00788
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1