MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

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

Event Description

The initial reporter stated they received discrepant thyroid test results for two samples from the same patient tested on two cobas 8000 e 602 module analyzers.Results from the following assays were affected: the elecsys tsh assay, the elecsys tsh ver.2 assay, and the elecsys ft4 iii assay.This medwatch will apply to the elecsys tsh ver.2 assay.Please refer to the medwatch patient identifier (b)(6) for information related to the elecsys tsh assay and refer to the medwatch patient identifier (b)(6) for information related to the elecsys ft4 iii assay.Sample 1 was tested on the customer's e 801 analyzer and an abbott architect analyzer on (b)(6) 2019.Sample 2 was initially tested with the tsh v.2 and ft4 assays on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on an abbott architect analyzer and a siemens centaur analyzer.The sample was also provided for investigation where it was tested with the tsh, tsh v.2, and ft4 assays on a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh ver.2 reagent lot number 473407, with an expiration date of july 2021 was used on this analyzer.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10739760
• MDR Text Key: 213685795
• Report Number: 1823260-2020-02670
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: ASKU
• Device Lot Number: 473407
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1