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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable thyroid results from a cobas 8000 e 801 module compared a wako accuraseed and an architect.Data that is a reportable malfunction for elecsys tsh assay, elecsys ft3 iii, elecsys ft4 iii assay for 1 patient was provided.This medwatch will cover ft4 iii.For information tsh and ft3 iii refer to the medwatch with patient identifiers (b)(6) respectively.There was no allegation of an adverse event.The serial number for the cobas e801 used by the customer is (b)(4).The serial number for the cobas e801 used at the investigation site is (b)(4).The tsh reagent lot used on this instrument is 365417 with an expiration date of feb-2020.The ft4 iii reagent lot used on this instrument is 380330 with an expiration date of dec-2019.The ft3 iii reagent lot used on this instrument is 348359 with an expiration date of oct-2019.Based on the data provided a general reagent issue can be excluded.The investigation concluded that all the thyroid parameter results were in concordance in relation to the normal reference ranges of the respective methods.The observed mathematically discrepant thyroid values between the various platforms are most likely due to the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.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
• 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: 8573193
• MDR Text Key: 143830224
• Report Number: 1823260-2019-01644
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: 04/10/2019
• 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