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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys ft4 iii assay on a cobas e 801 analytical unit, serial number (b)(4).Patient sample 1 initially resulted in an ft4 iii value of > 100 pmol/l accompanied by a data flag and repeated as 19.2 pmol/l.Patient sample 2 initially resulted in an ft4 iii value of > 100 pmol/l accompanied by a data flag and repeated as 16.7 pmol/l.Patient sample 3 initially resulted in an ft4 iii value of > 100 pmol/l accompanied by a data flag and repeated as 19.8 pmol/l.The repeat results were deemed correct as they were consistent with the clinical findings of the patients.The initial questionable results were reported outside of the laboratory.

Manufacturer Narrative

Na.

Manufacturer Narrative

The used reagent kit was calibrated four times on (b)(6) 2023 with unexpected low signals.The signals have risen again with time and with the fourth calibration to a normal level again.Based on the provided data a general product problem can be excluded.The investigation could not identify a product problem.The issue is consistent with foam on the reagent due to incorrect handling of the reagent pack.The foam would lead to false low signals and therewith falsely elevated ft4 results.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16732990
• MDR Text Key: 313436141
• Report Number: 1823260-2023-01251
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 05/04/2023

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 Expiration Date: 09/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 66068901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/04/2023
• 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