MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For 1 event, the investigation could not identify a product problem.The cause of the event could not be determined.For 1 event, the investigation is ongoing.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events.Questionable non-reproducible elecsys ft4 iii assay results were generated by a cobas 8000 e 602 module and a cobas 6000 e 601 module.The events involved a total of 14 patients.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

Manufacturer Narrative

For one pending event: the investigation determined one level of calibrator had a very high signal on the calibration that had been performed.An issue with the calibrator is suspected.The calibration did not fail because there is no upper limit existing for calibration acceptance.Only one level of control was measured and no controls covering the lower end of the measuring range were measured.The issue with calibration would have been detected had a lower level of control been tested.There were no follow up actions for this event.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9638532
• MDR Text Key: 219783541
• Report Number: 1823260-2020-90032
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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?: No
• Device Operator: No Information
• Device Model Number: FT4 G3
• Device Lot Number: ASKU, 426281
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2020
• Patient Sequence Number: 1