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 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc data were 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).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received questionable elecsys tsh assay and elecsys ft4 iii assay results for one patient with the cobas e 801 module serial number (b)(4).The customer reported the ft4 results to a physician who asked for a re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas e801 module, cobas e602 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e602 module serial number was (b)(4).The e411 serial number was (b)(4).The ft4 reagent lot number used with the e801 module at the investigation site was 460793 with an expiration date of 28-feb-2021.The ft4 reagent lot number used with the e602 module and the e411 analyzer was 478085 with an expiration date of 31-may-2021.Refer to the attachment on the medwatch for all patient data.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.

• 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: 11364626
• MDR Text Key: 255539555
• Report Number: 1823260-2021-00535
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 01/28/2021
• 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