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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc data was requested but not provided.The investigation did not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) and elecsys ft4 iii (ft4 iii) on a cobas e801 module compared to the abbott architect method.The results from the e801 module were reported outside of the laboratory where additional testing was requested.The sample was submitted for investigation where discrepant ft4 iii results were also identified by the centaur method and an e801 module used at the investigation site.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(4) for information on the ft3 iii results.Refer to the attached data for the patient results.The ft4 iii reagent lot number used at the investigation site was 460793 with an expiration date of feb-2021.The customer¿s e801 module serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).

• 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: 10992124
• MDR Text Key: 220972871
• Report Number: 1823260-2020-03177
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• 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
• Treatment: THYRADIN