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

Model Number FT4 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 09/26/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas 6000 e 601 module.The sample resulted in a ft4 value of 6.4 pmol/l (reference range = 12 - 22 pmol/l) and this value was reported outside of the laboratory.An endocrinologist requested for the sample to be repeated at another site using an equilibrium dialysis method.The result obtained with the equilibrium dialysis method was 1.7 ng/dl (reference range = 0.8 - 2.0 ng/dl).The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The complained sample was initially tested on (b)(6) 2021, resulting in a ft4 value of 6.37 pmol/l.Medwatch field b3 has been updated.The ft4 value of 1.7 ng/dl measured with the equilibrium dialysis method was measured on (b)(6) 2021.The sample was repeated at a second site on a second e 601 analyzer on (b)(6) 2021, resulting in a ft4 value of 0.40 ng/dl (5.15 pmol/l).The complained sample resulted in a t4 value of 17.88 nmol/l and a ft3 value of 1.77 pmol/l.Refer to the attachment for patient history and medications.Medwatch field d10 has been updated.

Manufacturer Narrative

The calibration signals generated at the customer site were ok.Controls recovered within specifications.No remaining sample material was available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 12727494
• MDR Text Key: 282044688
• Report Number: 1823260-2021-03183
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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

• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 01/03/2022
• Supplement Dates FDA Received: 12/22/2021; 01/06/2022
• 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
• Treatment: REFER TO THE ATTACHMENT FOR MEDICATIONS
• Patient Age: 86 YR
• Patient Sex: Female