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 06/19/2013

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for 9 samples from the same patient tested with thyroid assays on the cobas 8000 e 602 module.It is alleged that the patient was "misdiagnosed as being hyperthyroid." the following assays were affected: the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 assay, and roche diagnostics cobas elecsys anti-tpo.Roche manufactures two ft4 assays, the elecsys ft4 ii assay and the elecsys ft4 iii assay.It was asked, but it is not known which specific ft4 reagent was used.This medwatch will apply to the tsh assay.Patient identifier (b)(6) for information related to the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.Patient identifier (b)(6) for information related to the anti-tpo assay.Refer to the attachment for all patient data.No units of measure were provided for the assay results.The serial number of the e 602 analyzer 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: 9498378
• MDR Text Key: 219778811
• Report Number: 1823260-2019-04477
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HIBIOTIN