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

Catalog Number 09007784190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys t4 assay results for 3 patient samples on a cobas e 801 analytical unit.The customer questioned the high initial results which prompted them to repeat the samples.For sample 1, the initial t4 result was 24.9 ug/dl with flag.The sample was repeated and the repeat result was 13.9 ug/dl.The sample was repeated a third time the next day and the result was 8.56 ug/dl.For sample 2, the initial t4 result was 24.9 ug/dl with flag.The sample was repeated the next day and the repeat result was 8.47 ug/dl.For sample 3, the initial t4 result was 24.9 ug/dl with flag.The sample was repeated and the repeat result was 8.60 ug/dl.The sample was repeated a third time the next day and the result was 8.63 ug/dl.

Manufacturer Narrative

The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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
• MDR Report Key: 18801756
• MDR Text Key: 336529621
• Report Number: 1823260-2024-00582
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K961490
• 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: 04/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 09007784190
• Device Lot Number: 741920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/08/2024
• 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