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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer has been comparing an unspecified number of patient samples that had previously been run with the elecsys ft4 ii assay (ft4 ii) and repeating them with the elecsys ft4 iii assay (ft4 iii).The customer has been satisfied with most of the comparison results, however, the results for 1 patient sample were discrepant when compared between the two assay generations.The initial ft4 ii result was 45.6 pmol/l.The repeat result using ft4 iii was 14.85 pmol/l.The sample was repeated using ft4 ii and the result was 46.9 pmol/l.The repeat result using ft4 iii was 15.03 pmol/l.The sample was also sent to an external laboratory using the beckman dxi method and the result was 10.2 (units not provided).The results from each generation are similar.The customer now thinks the original ft4 ii result may have been too high and may have been due to an interfering factor.The initial ft4 ii result was reported outside of the laboratory.The ft4 iii results were generated for comparison purposes only.There was no allegation that an adverse event occurred.The cobas 8000 e 602 module serial number was (b)(4).

Manufacturer Narrative

The unit of measure for the beckman dxi result was pmol/l.Calibration signals at the customer site were ok.Based on the data provided, a general reagent issue can be excluded.The investigation was unable to find a definitive root cause.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7502043
• MDR Text Key: 108368205
• Report Number: 1823260-2018-01428
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• 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: 06/12/2018

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: 06437281190
• Device Lot Number: 28819700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1