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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys ft4 iii assay (ft4 iii) on a cobas 6000 e 601 module compared to the abbott method.The result from the e601 module was 39.94 pmol/l.This result was reported outside of the laboratory.On (b)(6) 2021 the sample was repeated by the abbott method with a result of 1.45 ng/dl (18.66 pmol/l).On (b)(6) 2021 the sample was also repeated by the beckman method with a result of 41.27 pmol/l which corresponded to the roche result.(b)(4).

Manufacturer Narrative

The initial report stated: "the e601 module serial number was (b)(6).This should state: "the e601 module serial number was either (b)(6) or (b)(6).Calibration and qc were acceptable.The sample was requested for investigation, however, the sample is no longer available.As no sample material was provided for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: 12882721
• MDR Text Key: 285937266
• Report Number: 1823260-2021-03513
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• 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: 12/22/2021

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: 05/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 547168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/22/2021
• 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: 24 YR
• Patient Sex: Male