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

Model Number	T4
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys t4 (t4) result from one patient sample tested on the cobas e 801 analytical unit.The initial result was 16.9 mg/dl.This result was deemed too high for the "patient's clinic".The first repeat result was 5.78 mg/dl.The second repeat result was 5.46 mg/dl.
Additional Manufacturer Narrative
The investigation noted that the initial and repeat results were from different reagent packs.The first reagent pack which gave the initial questionable result had film/foam/bubbles on the surface, causing the pipetting of an insufficient reagent volume.The investigation reviewed the calibration data from the second reagent pack; the results were within specifications but on the low side.The investigation reviewed the qc data.The qc data of the first reagent pack had an error alarm.The qc data of the second reagent pack were within specifications.The field service engineer performed preventive maintenance on the analyzer and replaced the measuring cells.He performed an instrument check with successful results.A general reagent issue can be excluded based on the information provided.The investigation determined the event was consistent with film/foam/bubbles on the reagent surface product labeling states "avoid foam formation in all reagents and sample types (specimens, calibrators and controls).".

• 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: 20533698
• Report Number: 1823260-2024-03082
• Device Sequence Number: 15146884
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 11/19/2024

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 Model Number: T4
• Device Catalogue Number: 09007784190
• Device Lot Number: 790382
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN; LEVOTIROXINA; METFORMINA
• Patient Age: 50 YR
• Patient Sex: Female