MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; 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 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation could not identify a product problem.The cause of the event could not be determined.There was no remaining sample available for further investigation.

Event Description

The initial reporter stated they received discrepant thyroid test results for one patient sample tested on two cobas 8000 e 801 module analyzers and a cobas e 411 immunoassay analyzer.The following assays were affected: elecsys ft3 iii, the elecsys tsh assay, and the elecsys tsh assay ver.2.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the tsh ver.2 assay.Please refer to the medwatch with patient identifier pt-(b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier pt- (b)(6) for information related to tsh.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on 13-oct-2020.At the customer site, the sample was also treated with polyethylene glycol (peg) and repeated on the customer's e 801 analyzer.The tsh ver.2 assay was also repeated on the customer's e 801 analyzer after x2, x5, and x10 dilutions.The sample was repeated using the wako accuraseed and abbott architect methods.The sample was also provided for investigation, where it was tested for tsh, tsh ver.2, and ft3 on a second e 801 analyzer used for investigation.During investigations, the sample was also tested for ft3 on an e411 analyzer.The serial number of the customer's e 801 analyzer is (b)(4).The tsh ver.2 reagent lot number and expiration date used on this analyzer is unknown.The serial number of the e 801 analyzer used for investigation is 14d9-06.Tsh ver.2 reagent lot number 479739, with an expiration date of september 2021 was used on this analyzer.

• Brand Name: ELECSYS TSH ASSAY
• 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: 11045731
• MDR Text Key: 242317770
• Report Number: 1823260-2020-03306
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 08443432190
• Device Lot Number: ASKU, 479739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• 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
• Patient Age: 79 YR