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

Catalog Number 07976887190

Device Problems Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 analyzer was (b)(6).Quality controls were acceptable.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for patient samples tested with elecsys ft4 iii on a cobas e 801 analytical unit.When switching to a new reagent pack, the first few samples recovered values above the measuring range of the assay.When repeated, these samples recovered normal values.The customer provided an example of one patient sample with discrepant ft4 results.No questionable results were reported outside of the laboratory.This sample initially resulted in an ft4 value of > 100.00 pmol/l with a data flag.This value did not match the patient's clinical diagnosis.The sample was repeated, resulting in an ft4 value of 19.50 pmol/l.

Manufacturer Narrative

A general reagent issue can be ruled out because the qc prior to the event was within ranges and afterwards, the reagent worked as intended.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19088318
• MDR Text Key: 339984982
• Report Number: 1823260-2024-01106
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 05/03/2024

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 Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1