MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up/corrective actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction events.An erroneous incorrect measurement was generated for elecsys ft3 iii.The event involved 1 patient where the result from a cobas 6000 e 601 module did not match the clinical picture of the patient.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8549767
• MDR Text Key: 143411756
• Report Number: 1823260-2019-90114
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: 341685
• Type of Device Usage: N
• Patient Sequence Number: 1