MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number 07027869190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).Reporter facility name: the full facility name was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys t3 on a cobas 8000 e 801 module (serial number (b)(4)).No incorrect results were reported outside of the laboratory.The sample was tested twice on the customer's e 801 analyzer, resulting in t3 values of 6.51 ng/ml and 6.51 ng/ml (reference range = 0.8 - 2.0 ng/ml).The sample was frozen and then sent to two other sites for testing on an abbott analyzer and a siemens analyzer.The sample was repeated on an abbott analyzer, resulting in a t3 value of 1.13 ng/ml (reference range = 0.35 - 1.93 ng/ml).The sample was also repeated on a siemens analyzer, resulting in a t3 value of 1.13 ng/ml (reference range = 0.6 - 1.81 ng/ml).

Manufacturer Narrative

One sample was sent for investigation.An interfering factor against sa could be identified in the sample.The customer¿s high t3 results were reproduced.The result of ft3iii was detected above the reference range with an analyzer with prewash.An influence of prewash could be seen for t3 assay the rarely occurring event of streptavidin interfering factors is covered by a disclaimer in the section limitation - interference in the method sheets of all applicable products: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by a suitable test design.The investigation did not identify a product problem.

• Brand Name: ELECSYS T3
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11975623
• MDR Text Key: 270679791
• Report Number: 1823260-2021-01712
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• PMA/PMN Number: K962508
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027869190
• Device Lot Number: 48099901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1