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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 ii assay on a cobas e 411 immunoassay analyzer.The erroneous results were reported outside of the laboratory.The results did not compare to values measured on an abbott architect analyzer.The sample was provided for investigation, where it was tested on a second e411 analyzer.In addition to testing ft3 and ft4 ii on this second e411 analyzer, the sample was also tested with the elecsys ft4 iii assay.The value measured for ft4 iii was also erroneous.The sample was also tested on a centaur analyzer.This medwatch will apply to the ft4 iii assay.Please 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 ii assay.No adverse events were alleged to have occurred with the patient.The serial number of the customer's e411 analyzer is (b)(4).The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 iii reagent lot number 331797, with an expiration date of may 2019 was used on this analyzer.In relation to the differences seen with ft4 ii, ft4 iii, and ft3 values generated from the sample, different 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.A general reagent issue can most likely be excluded.

• 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: 7894911
• MDR Text Key: 120973203
• Report Number: 1823260-2018-03216
• 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: 09/20/2018

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: ASKU
• Device Lot Number: 331797
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/20/2018
• 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
• Patient Age: 40 YR