MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The customer performed a visual inspection of the samples and no abnormalities were found.The field service engineer checked the customer's calibration and qc results and confirmed all results were within the acceptable limits during the sample runs.He reviewed the alarm trace and confirmed no alarms were encountered during the sample runs.He checked the probe and bead mixer and confirmed those were aligned.He checked the customer's maintenance and verified the maintenance was ok.He confirmed the measuring cell was due to be exchanged.The investigation reviewed the customer's calibration and qc results and the results were within the acceptable ranges.A reagent issue with the ft4 assay could be excluded.The investigation did not find any abnormalities with the customer's sample pre-analytics or with the e411 system alarm trace.Based on the provided information, the investigation did not identify a product problem.

Event Description

The initial reporter received questionable elecsys ft4 iii results for one patient tested on a cobas e411 disk serial number (b)(4).On (b)(6) 2022, the patient's sample was initially tested on a beckman coulter access analyzer.The customer performed testing with the sample on the e411 disk analyzer and the elecsys ft4 results were not reported outside the laboratory.The patient's beckman coulter access ft4 result was 39.11 pmol/l.The patient's elecsys ft4 results with reagent lot number 579081 were 13.39 pmol/l, 13.51 pmol/l, and 13.67 pmol/l.On (b)(6) 2022, the patient had a second sample collected.The patient's sample was initially tested on a beckman coulter access analyzer.The customer performed testing with the sample on the e411 disk analyzer and the elecsys ft4 results were not reported outside the laboratory.The customer sent the sample to a different laboratory and the sample was tested on an unknown roche analyzer.The patient's beckman coulter access ft4 result was 37.13 pmol/l.The patient's elecsys ft4 result with reagent lot 59321901 was 13.91 pmol/l.The patient's elecsys ft4 result with a new reagent pack of lot 59321901 was 11.20 pmol/l.The patient's elecsys ft4 result at the different laboratory was 11.34 pmol/l.The ft4 reagent lot number 579081 had an expiration date requested but was not provided.The ft4 reagent lot number 59321901 had an expiration date of 31-dec-2022.The ft4 reagent lot number and expiration date used for testing at the different laboratory were requested but not provided.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14572339
• MDR Text Key: 301833717
• Report Number: 1823260-2022-01575
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 59321901, 579081, ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1