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 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys tsh assay (tsh version 1) on the customer's cobas 8000 e 801 module and with the tsh version 1 assay and the elecsys tsh ver.2 assay (tsh version 2) on a second e 801 analyzer used for investigation.The samples were initially tested using tsh version 1 (lot unknown) on the customer's e 801 analyzer.The samples were provided for investigation and tested with both tsh version 1 (lot 454296, expiration unknown) and tsh version 2 (lot 473407, expiration unknown) on the second e 801 analyzer on (b)(6) 2020.This medwatch will apply to the tsh version 1 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh version 2 assay.The reference range used for both the tsh version 1 and version 2 assays is 0.5 - 5.00 uiu/ml.The first sample resulted as 0.674 when tested using the tsh version 1 assay on the customer's e 801 analyzer.This sample resulted with a value of 0.224 when tested using tsh version 1 assay and a value of 0.224 when tested using the tsh version 2 assay on the e 801 system used for investigation.The second sample resulted as 0.906 when tested using the tsh version 1 assay on the customer's e 801 analyzer.This sample resulted with a value of 0.277 when tested using tsh version 1 assay and a value of 0.261 when tested using the tsh version 2 assay on the e 801 system used for investigation.The third sample resulted as 5.17 when tested using the tsh version 1 assay on the customer's e 801 analyzer.This sample resulted with a value of 3.46 when tested using tsh version 1 assay and a value of 3.22 when tested using the tsh version 2 assay on the e 801 system used for investigation.The serial number of the e 801 analyzer used by the customer is unknown.The serial number of the e 801 analyzer used for investigation is (b)(4).

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 10212807
• MDR Text Key: 202941891
• Report Number: 1823260-2020-01577
• 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: 08/25/2020

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: TSH
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1