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 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the lumipulse method.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the ft4 iii results.The ft4 iii result from the e801 module was > 7.77 ng/dl.The repeat from the lumipulse method was 1.18 ng/dl.The tsh result from the e801 module was 2.03 uiu/ml.The repeat from the lumipulse method was 1.39 uiu/ml.The ft3 iii result from the e801 module was 6.67 pg/ml.The repeat from the lumipulse method was 3.33 pg/ml.The erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).

Manufacturer Narrative

The sample was tested at the investigation site using e801 module serial number (b)(4): the ft4 iii result was 1.38 ng/dl with reagent lot 380330 expiring dec-2019.The tsh result was 66.9 uiu/ml with reagent lot 331814 expiring aug-2019.The ft3 iii result was 8.62 pg/ml with reagent lot 348359 expiring oct-2019.Was updated.

Manufacturer Narrative

No sample material could be provided for further investigation.From the data provided, a general reagent issue can be excluded.The investigation did 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: 8585830
• MDR Text Key: 144275083
• Report Number: 1823260-2019-01711
• 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,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1