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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii assay, elecsys tsh assay, and elecsys ft3 iii results for one patient tested on two cobas 8000 e801 modules.The customer provided a serial number for one e801 module, (b)(4).The questionable results were not reported outside the laboratory.The patient¿s sample was sent to another laboratory and tested twice on an abbott analyzer.Only one result was provided for each elecsys and abbott test.The e801 module used for each elecsys test was requested, but not provided.The patient¿s initial ft4 result on the e801 was 3.73 pg/ml; the repeat on the abbott was 2.62 pg/ml.The patient¿s initial tsh result on the e801 was 11.900 lu/ml; the repeat on the abbott was 0.004 lu/ml.The patient¿s initial ft3 result on the e801 was 4.69 ng/dl; the repeat on the abbott was 3.83 ng/dl.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the tsh assay and patient identifier (b)(6) for the ft3 assay.

Manufacturer Narrative

Fields a2 and a3 updated.The client performed another test for the patient on (b)(6)2021.The patient's initial results were from a cobas pro analyzer and the repeats were from an abbott analyzer using a cmia method.No serial numbers were provided.The patient's initial tsh result was 12.200 ¿iu/ml; the repeat was < 0.004 ¿iu/ml.The patient's initial ft4 result was 3.90 ng/dl; the repeat was 2.58 ng/dl.The patient's initial ft3 result was 5.14 pg/ml; the repeat was 4.40 pg/ml.The investigation is ongoing.

Manufacturer Narrative

The investigation found the results from both the roche and abbott methods were above the published reference ranges and lead to the same clinical interpretation.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12771823
• MDR Text Key: 280527401
• Report Number: 1823260-2021-03265
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K131244
• 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,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 541093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female