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

Model Number FT4 G3

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter questioned thyroid results for 1 patient sample tested on a cobas e801 module.The initial results were reported outside of the laboratory where they were questioned.The sample was repeated on the e801 module and the results were questioned as they did not correspond to the patient¿s clinical condition.The sample was repeated on an e801 module at a different hospital, a siemens centaur analyzer, a beckman au analyzer and a mandary cl6000 analyzer where discrepant results were identified for elecsys t4 (t4), t3, ft3 and ft4.The results from the siemens method were believed to be correct.This medwatch will cover ft4.Refer to medwatch with patient (b)(6) for information on the t4 results, medwatch with patient (b)(6) for information on the t3 results and medwatch with patient (b)(6) for information on the ft3 results.Refer to the attachment for the patient results.The cobas 8000 core unit serial number was 21z3-06.Neither the customer¿s e801 module serial number or the serial number for the other hospital¿s e801 module were provided.

Manufacturer Narrative

The sample was no longer available for investigation.As the sample was no longer available, the cause of the event could not be determined.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: 14268826
• MDR Text Key: 299557095
• Report Number: 1823260-2022-01240
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: ASKU
• 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: 06/13/2022

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/13/2022
• 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: 59 YR
• Patient Sex: Female