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

Catalog Number	09007784190
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 71166800.The expiration date was requested but was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable t4 results from the cobas e 801 analytical unit.After a failed calibration, the customer repeated three patient samples for a patient correlation.Sample 1 initial result was 9.29 ug/dl and the repeat result was 13.2 ug/dl.Sample 2 initial result was 5.86 ug/dl and the repeat result was 10.9 ug/dl.Sample 3 initial result was 7.3 ug/dl and the repeat result was 11.6 ug/dl.The initial results were believed correct.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The field service engineer checked the analyzer and was not able to determine a root cause.He ran instrument checks which passed and loaded a new reagent pack.The customer performed calibration, qc, and precision testing which passed.The customer repeated the affected patient samples and the results were consistent with the correct values.The investigation was not able to identify a specific root cause.The issue was consistent with a handling or other issue with the suspected reagent pack.

• 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 46250-0457
• MDR Report Key: 18825458
• Report Number: 1823260-2024-00637
• Device Sequence Number: 3047169
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024
• 2 Devices were Involved in the Event: 1 2

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: 09007784190
• Device Lot Number: 71166800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 58 YR
• Patient Sex: Female