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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys tsh, elecsys tsh v2, elecsys ft4 iii, elecsys ft3 iii and elecsys ft3 iii ver.2 assay results for three patient samples tested on the cobas e 801 module with serial number (b)(4).It is unknown if the initial results were reported outside of the laboratory.The hospital asked that the samples be remeasured because the tsh, ft4, and ft3 results did not match each other.The patient's sample was sent to an investigation site that uses an e 801 with serial number (b)(4) and an e 411 with serial number (b)(4).The ft4 iii reagent lot number used at the investigation site's e 801 is 572941 with an expiration date of 30-sep-2022.The ft4 iii reagent lot number used at the investigation site's e 411 is 579081 with an expiration date of 31-oct-2022.The patient's sample was also sent to an outsourced laboratory that uses an abbott architect with an unknown laboratory method.Refer to the highlighted sections of the attachment in the medwatch for the questionable patient results.This medwatch is for the ft4 assay.Refer to the medwatch with patient identifier (b)(6) for the tsh v2 assay and medwatch with patient identifier (b)(6) for the ft3 assay, medwatch with patient identifier (b)(6) for the ft3 v2 assay and medwatch with patient identifier (b)(6) for the tsh assay.

Manufacturer Narrative

The calibration and qc data from the investigation site did not indicate any issues.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/methods, and the standardization methodology used.Based on the data provided, a general reagent issue can be excluded.An interfering factor can also be excluded.

• Brand Name: ELECSYS FT4 III
• 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: 14621037
• MDR Text Key: 301183113
• Report Number: 1823260-2022-01651
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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 Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/21/2022
• 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