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 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 46 patient samples tested for ft4 iii assay on a cobas 8000 e 801 module compared to the beckman dxl.Of the data provided, there were 7 patient samples with discrepant ft4 iii and elecsys tsh assay results, 21 patient samples with discrepant ft4 iii results, and 9 patient samples with discrepant tsh results.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results.The e 801 module serial number was (b)(4).

Manufacturer Narrative

No samples were returned for investigation.Differences in results and reference ranges from tsh assays by different manufactures, in this case abbott, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.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: 8887465
• MDR Text Key: 154169483
• Report Number: 1823260-2019-02961
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1