MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	12017709122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e601 module is (b)(6).The patient sample collected on 31-aug-2023 was received for investigation.The investigation performed an initial test to check for interference.The investigation did not find any significant changes for tsh, ft4 iii, t4 v2, and t4 v3 assays.There were also no significant t4 concentration differences between testing with the different versions of the t4 assays.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys t4 (t4) and elecsys ft4 (ft4) results from two samples from the same patient tested on the cobas 6000 e601 module.This medwatch is for the t4 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the ft4 assay.The initial results were reported outside of the laboratory.The doctor questioned the results as they did not match the patient's clinical diagnosis.The reporter then sent the patient samples to another laboratory that uses beckman, abbott, and siemens centaur analyzers.The reporter stated that they think that the results from the abbott analyzer matched the patient's clinical diagnosis.The reporter wants to know if there was an interference with the roche assays.Please refer to the attachment (b)(6) in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
The patient sample was further tested using a heterophilic blocking tube (hbt) treatment; no significant changes were found for the ft4 iii and t4 results.No interfering factors were identified.The cause of the event could not be determined.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS T4
• Common Device Name: RADIOIMMUNOASSAY, TOTAL 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
• MDR Report Key: 17816456
• Report Number: 1823260-2023-03091
• Device Sequence Number: 16719811
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K961490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 12017709122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female