MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.

Event Description

The initial reporter complained that results for 1 patient tested for elecsys ft3 iii (ft3 iii), elecsys ft4 iii (ft4 iii) and elecsys tsh (tsh) on a cobas e 801 module do not fit the patient's clinical picture.The ft4 iii were discrepant when compared to the abbott method.The date of event is an approximation as the date of event was unknown.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with a1 patient identifier (b)(6) for information on the ft4 iii results.The e801 module serial number was (b)(4).

Manufacturer Narrative

The sample was received for investigation.No interfering factor was identified.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials 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: 9465526
• MDR Text Key: 219765565
• Report Number: 1823260-2019-04404
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 08443432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARBIMAZOL
• Patient Age: 60 YR