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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The rack adapters were not used.The investigation determined that the calibration and qc were acceptable.There was no indication of a general reagent or instrument performance issue.The investigation did not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 5 patients tested for elecsys ft4 iii assay on a cobas 6000 e 601 module.For patient 1 the initial ft4 iii result was 41.31 pmol/l.On (b)(6) 2019 the repeat result was 18.12 pmol/l.For patient 2 the initial ft4 iii result was 37.44 pmol/l.On (b)(6) 2019 the repeat result was 17.07 pmol/l.For patient 3 the initial ft4 iii result was 34.11 pmol/l.On (b)(6) 2019 the repeat result was 15.3 pmol/l.For patient 4 the initial ft4 iii result was 28.41 pmol/l.On (b)(6) 2019 the repeat result was12.78 pmol/l.For patient 5 the initial ft4 iii result was 29.49 pmol/l.On (b)(6) 2019 the repeat result was 10.51 pmol/l.The initial results were reported outside of the laboratory.There was no allegation of an adverse event.The ft4 iii reagent lot number was 378826.

• 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: 8611230
• MDR Text Key: 145101700
• Report Number: 1823260-2019-01817
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2019

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 Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/15/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1