MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft3 iii results for 1 patient sample and questionable elecsys ft3 iii results and elecsys ft4 iii assay for 1 patient sample on cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the ft3 assay.Please refer to medwatch mdr-47505 for the alleged ft4 assay results for 1 of the patient samples.See highlighted section of attachment "cn551012.Pdf" for patient results.The results were not reported outside of the laboratory.

Manufacturer Narrative

The customer's sample was returned for investigation.The sample was investigated with a dedicated research toolbox to detect streptavidin interfering factors.A decreased amount of counts was generated with the kit version that contains an additional amount of a given streptavidin blocking agent.This does not indicate the presence of a streptavidin interfering factor.With a research version of the ft3 assay that contains an additional amount of a given iep (interference eliminating protein), a non-significant increase of the ft3 value was measured compared to the value generated with the commercially available assay.Once again, this does not indicate that an streptavidin interfering factor is available in the sample analyzed.Although no interfering factor could be identified during the analysis of the sample, an interfering factor may have been available in the sample.The effect of the latter on the value of the ft3 assay may have been minimalized by the different freeze/thaw cycles of the sample concerned.From the information provided and the analysis thereof, a general reagent issue most likely can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10691213
• MDR Text Key: 227988034
• Report Number: 1823260-2020-02567
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• PMA/PMN Number: K963127
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1