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 Consequences Or Impact To Patient (2199)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The initial reporter stated that they have observed imprecision on quality controls and discrepant results for one patient sample tested with the elecsys ft4 iii assay lot 391521 on two cobas 8000 e 602 module analyzers.Since introducing the lot, the reporter states that they had to re-calibrate multiple times on both analyzers.No incorrect results were reported outside of the laboratory.The patient sample initially resulted with an ft4 value of 61.03 pmol/l when tested on the first e 602 analyzer.The sample was repeated on the second e 602 analyzer, resulting with a value of 54.19 pmol/l.The sample was also repeated on the first e 602 analyzer, resulting with a value of 49.21 pmol/l.No adverse events were alleged to have occurred with the patient.The serial number of the first e 602 analyzer is (b)(4) and the serial number of the second e 602 analyzer is (b)(4).

Manufacturer Narrative

The observed discrepancy of elecsys ft4 iii assay values for the patient sample in question were generated due to the initial run on reagent with out of range qc results.After re-calibration and within range qc, elecsys ft4 iii assay recovery for patient sample was most likely correct.Both the initial and repeat results were above the reference range of the assay.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8704258
• MDR Text Key: 148212951
• Report Number: 1823260-2019-02215
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 391521
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1