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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The sample resulted with a tsh value of 0.04 uiu/ml when tested on the e 801 analyzer.The sample was repeated on an architect analyzer, resulting with a tsh value of 0.027 uiu/ml.The sample was treated with polyethylene glycol (peg) and repeated for tsh on the e 801 analyzer, resulting with a 100 % recovery.The sample resulted with a ft3 value of 7.47 pg/ml when tested on the e 801 analyzer.The sample was repeated on an architect analyzer, resulting with a ft3 value of 4.63 pg/ml.The sample was treated with polyethylene glycol (peg) and repeated for ft3 on the e 801 analyzer, resulting with a 72.8 % recovery.The sample resulted with a ft4 value of 2.98 ng/dl when tested on the e 801 analyzer.The sample was repeated on an architect analyzer, resulting with a ft4 value of 1.38 ng/dl.The sample was treated with polyethylene glycol (peg) and repeated for ft4 on the e 801 analyzer, resulting with a 114.8 % recovery.The e801 analyzer serial number is (b)(4).

Manufacturer Narrative

One sample was sent for additional investigation for possible interfering factors.Based on the available data, an interfering factor could be excluded and a general reagent issue could be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.The investigation did not identify a product problem.

• 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: 9340872
• MDR Text Key: 219608848
• Report Number: 1823260-2019-04102
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYRADIN