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 Consequences Or Impact To Patient (2199)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi) # (b)(4).The patient's sample was returned for investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft3 iii and elecsys ft4 iii assay results for 1 patient sample on a cobas 8000 e 801 module, serial number (b)(4).This medwatch covers the ft4 iii patient results.Refer to medwatch with patient identifier (b)(6) for information regarding ft3 iii results.The results were reported outside of the laboratory.

Manufacturer Narrative

The patient sample was returned for investigation.A streptavidin interfering factor can be excluded.The discrepant ft4 results between elecsys and siemens are most likely based on well-recognized methodological differences.A general product problem could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 11423531
• MDR Text Key: 268487226
• Report Number: 1823260-2021-00664
• 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: 05/10/2021

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1