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 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys t4 (t4) and elecsys t3 (t3) on a cobas 801 module compared to a cobas e 411 immunoassay analyzer and 2 different cobas 6000 e 601 modules.Based on the data provided, the patient's elecsys tsh (tsh) and t3 results are a reportable malfunction.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the t3 results.No 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).The customer took another sample from the patient but got the same questionable results.The customer ran other patient samples between the e601 module and the e801 module and got results that were comparable to one another.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.

• 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: 8573094
• MDR Text Key: 143831699
• Report Number: 1823260-2019-01638
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: 365417
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR