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

Model Number FT4 G2

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

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer could not determine a cause.Residue was noticed on the sample probe tip.The pump pressure was verified, pinch tubing was replaced, and probe adjustments were performed.The system went into standby with no alarms.The customer ran controls and results were within expectations.

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with the elecsys ft4 ii assay on a cobas 6000 e 601 module.The sample resulted in a ft4 value of 4.69 ng/dl (reference range = 0.74 - 1.55 ng/dl) when tested on the e 601 analyzer.The result was reported outside of the laboratory and questioned since it was different from a previous result of the patient.The sample was sent to another laboratory to run on an unknown roche analyzer, resulting in a ft4 value of 1.27 ng/dl (reference range = 0.82 - 1.77 ng/dl).The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The last calibration was performed on 21-jul-2021.One level of control was outside of range for ft4.The issue was solved at the customer site by replacing the reagent.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch field d4 has been updated.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12354010
• MDR Text Key: 268943217
• Report Number: 1823260-2021-02434
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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 Model Number: FT4 G2
• Device Catalogue Number: 06437281160
• Device Lot Number: 494381
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR