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

Model Number FT4 G3

Device Problem Low Test Results (2458)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii assay and elecsys ft3 iii ver.2 results for one patient sample tested on the cobas 8000 e801 module.The initial result was reported outside of the laboratory.The physician asked for a rerun of the sample at the investigation site.The sample was also sent out to an outsourced laboratory.The serial number of the customer's e 801 is (b)(4).The serial number of the investigation site's e 801 is (b)(4).The lot number of the ft4 iii reagent used at the investigation site is 57294 with an expiration date of 30-sep-2022.Refer to the highlighted sections of the attachment in the medwatch for the questionable results.This medwatch is for the ft4 iii assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 iii v2 assay.

Manufacturer Narrative

The investigation determined that in relation to the differences in the ft3 and ft4 values generated with different analyzers, assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation excluded an interfering factor in the sample.The investigation excluded a general reagent issue.The investigation did not identify a product problem.

• 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: 14801988
• MDR Text Key: 303247768
• Report Number: 1823260-2022-01849
• 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: 07/22/2022

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/22/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Female