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

Catalog Number 09043276190

Device Problem Low Test Results (2458)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The tsh and ferritin tests were performed on e602 module serial number (b)(6).The ft4 iv test was performed on e602 module serial number (b)(6).Qc was acceptable.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iv (ft4 iv), elecsys ferritin (ferritin), and elecsys tsh (tsh) on 2 cobas 8000 e 602 modules.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ferritin results and medwatch with a1 patient identifier (b)(6) for information on the tsh results.The initial tsh result was 0.029 uiu/ml.The repeat result was 2.90 uiu/ml.The initial ft4 iv result was 0.039 ng/dl.The repeat result was 1.26 ng/dl.The initial ferritin result was 1.01 ng/ml.The repeat result was 35.94 ng/ml.

Manufacturer Narrative

The repeat results were believed to be correct.Calibration data was acceptable.Based on the calibration and qc data, a general reagent issue can be excluded.The specific cause of the event could not be determined.The investigation determined the event was consistent with a pre-analytical handling issue.

• 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: 18210067
• MDR Text Key: 329024424
• Report Number: 1823260-2023-03764
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09043276190
• Device Lot Number: 72489601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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
• Patient Age: 12 MO
• Patient Sex: Female