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

Model Number FT4 G2

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Both the calibration and qc testing performed at the investigation site was acceptable.To the differences of the tsh, ft4 ii, and ft iii values generated between the assays from roche diagnostics and abbott architect: different assays from different vendors may generate different values.This relates to the different setups of the assay, the different antibodies used and the different standardization materials/procedures used.Based on the information provided a general reagent issue can most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of questionable thyroid results from a cobas 8000 e 801 module compared to an abbott architect.The customer provided that patient data for one patient that had reportable malfunctions for elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft4 ii assay.This medwatch will cover ft4 ii for information tsh and ft4 iii refer to the medwatch with patient identifiers (b)(6) respectively.The results in question were reported outside of the laboratory.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 ii reagent lot used on this instrument is 341695 with an expiration date of sep-2019.The ft4 iii reagent lot used on this instrument is 380330 with an expiration date of dec-2019.

• 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: 8772241
• MDR Text Key: 150754858
• Report Number: 1823260-2019-02481
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 341695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2019
• 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
• Patient Age: 71 YR