MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 07027737214

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number and model of the roche analyzer used at the customer site were requested, but not provided.Ft4 reagent lot number 679481, with an expiration date of 01-nov-2023 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(6).Ft4 reagent lot number 679481, with an expiration date of 01-nov-2023 was used on this analyzer.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys prolactin ii and elecsys ft4 iv on an unknown roche analyzer at the customer site and on a cobas e 801 module used for investigation.This medwatch will apply to the ft4 assay.Please refer to the medwatch with a1 patient identifier (b)(6) for information related to the prolactin assay.Refer to the attachment for all patient data.The sample was initially tested at the customer site on (b)(6) 2023.The sample was provided for investigation, where it was tested on an e 801 analyzer on (b)(6) 2023.The sample was also repeated on an abbott architect analyzer.

Manufacturer Narrative

No sample material was available for further investigation.The investigation determined there was no information that reasonably suggests there was a device malfunction.There was no hint of a general reagent issue.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17816622
• MDR Text Key: 324238298
• Report Number: 1823260-2023-03095
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K220456
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 07027737214
• Device Lot Number: 679481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female