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 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for 1 patient sample on a cobas 8000 e 801 module compared to competitor methods.The initial results from the customer's e 801 were reported outside of the laboratory.The competitor methods were considered correct.There were discrepant results for elecsys ft3 iii, elecsys prolactin assay, elecsys estradiol assay, elecsys testosterone ii assay from the customer's e 801 module compared the siemens centaur method.There were discrepant results for elecsys tsh assay from the customer's e 801 module compared to the siemens centaur and beckman methods.There were discrepant results for roche diagnostics cobas elecsys anti-tpo from the customer's e 801 module compared to the beckman method.There were discrepant results for elecsys dhea-s from the customer's e 801 module compared to the siemens immulite 2000 method.This medwatch will cover tsh refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results, medwatch with patient identifier (b)(6) for information on the prolactin results, medwatch with patient identifier (b)(6) for information on the estradiol results, medwatch with patient identifier (b)(6) for information on the testosterone results, medwatch with patient identifier (b)(6) for information on the anti-tpo results, and medwatch with patient identifier (b)(6) for information on the dhea-s results.The customer's cobas e 602 module serial number was not provided.

Manufacturer Narrative

One patient sample was returned for investigation.The differences of the tsh values, generated with the analyzers from roche diagnostics and siemens, are caused by differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.

• 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: 9151869
• MDR Text Key: 203493418
• Report Number: 1823260-2019-03550
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11731459122
• Device Lot Number: 40413000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: L-THYROXIN.