MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 09043284190

Device Problem Low Test Results (2458)

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

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e 801 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys tsh and elecsys ft4 iv results from one patient sample tested on the cobas e 801 module.This mdr is for the ft4 iv assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the tsh assay.The initial results were reported to the doctor.On (b)(6) 2023, the initial ft4 result was 0.968 pmol/l.This result was reported as 1.31 pmol/l (the limit of quantification loq of the assay).On (b)(6) 2023, the repeat result was 16.4 pmol/l.

Manufacturer Narrative

The investigation reviewed the calibrations; the results were within specifications.The investigation reviewed the qc data; the qc results were within specifications.A general reagent issue can most likely be excluded based on the calibration and qc results.The investigation determined the event was consistent with a preanalytic issue (pipetting of an insufficient amount of sample or foam/air bubbles on the sample surface) at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• Brand Name: ELECSYS FT4 IV
• Type of Device: 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: 18028333
• MDR Text Key: 326798964
• Report Number: 1823260-2023-03453
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: K220456
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 09043284190
• Device Lot Number: 67063401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• 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