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

Model Number FT4 G2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

From the information provided, a general reagent issue can be excluded.Assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.The sample also had discrepant results for the elecsys ft4 ii assay when tested on the e 801 analyzer that was used for investigation.Incorrect results were reported outside of the laboratory.This medwatch will apply to the ft4 ii assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay.The sample was initially tested using the customer's e 801 analyzer and repeated using the wako accuraseed method on (b)(6) 2019.The sample was also repeated on an abbott architect analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019.The customer's e 801 analyzer serial number is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 ii reagent lot number 363195, with an expiration date of december 2019 was used on this analyzer.

• Brand Name: ELECSYS FT4 II 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: 9106535
• MDR Text Key: 216863210
• Report Number: 1823260-2019-03410
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• 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: 09/23/2019

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 Expiration Date: 12/31/2019
• Device Model Number: FT4 G2
• Device Catalogue Number: 06437281190
• Device Lot Number: 363195
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/23/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1