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

Catalog Number 07976887190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained that the results for multiple patients tested for elecsys ft4 ii (ft4 ii) and elecsys ft4 iii (ft4 iii) (b)(6) 2018 on a cobas e801 module do not match the clinical picture for these patients.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.The customer provided data for 16 patient samples tested (b)(6) 2018.The customer changed ft4 generations within this time period.The oldest patient samples were tested with ft4 ii and the most recent samples were tested with ft4 iii.The specific date of when patients were tested with ft4 ii versus ft4 iii was not provided.Clinically, the results between ft4 ii and ft4 iii correlate very well.The ft4 ii and ft4 iii results were reported outside of the laboratory where the endocrinologists complained about the results.The patient samples were repeated by another method but the customer declined to provide the actual results.The results by the other method were "normal." there was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).

Manufacturer Narrative

The 16 patient samples were submitted for investigation.The customer's high ft4 ii results were reproduced in 15 of the 16 patient samples.Ft4 iii results were comparable to the ft4 ii results and higher than the reference range.Sample id (b)(6) shows values within the reference ranges for all measured parameters.Sample id (b)(6) was investigated further to test for a biotin interference.No biotin was measured in this patient sample and would not be a cause for the elevated results.Samples id (b)(6) were sent to an external laboratory to be measured by the siemens centaur method.The results from the siemens method compared well to the results from the roche method."some" of the patient results seem to be plausible based on the medication they are taking.A reagent specific issue was not identified.The reagent is performing within specification.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7521742
• MDR Text Key: 108502203
• Report Number: 1823260-2018-01523
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 304694
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR