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

Catalog Number 09007784190

Device Problems Mechanical Problem (1384); Non Reproducible Results (4029)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number was 71166800.The expiration date was requested but was not provided.The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337077272
• Report Number: 1823260-2024-00637
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 09007784190
• Device Lot Number: 71166800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/28/2024
• 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: 58 YR
• Patient Sex: Female