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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

Sample material was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii, elecsys ft3 iii, and tsh elecsys results for 1 patient on a cobas 8000 cobas e 602 module, serial number, (b)(4).This medwatch covers the alleged results for the ft4 assay.Please refer to medwatch mdr-67077 for the alleged ft3 assay results and medwatch mdr-67078 for the alleged tsh assay results.The results were reported to the patient's endocrinologist, who requested the sample test be repeated due to the results not matching the patient's clinical picture.The patient's results obtained with cmia (chemiluminescent microparticle immunoassay) technology were considered to be clinically correlating with the patient.The customer suspects an interference.

Manufacturer Narrative

The customer's calibration and qc results and sample pre-analytic details were requested but not provided.The sample could not be provided for investigation.The investigation did 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: 13666215
• MDR Text Key: 292816345
• Report Number: 1823260-2022-00571
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

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: ASKU
• Device Lot Number: 579081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 04/15/2022
• 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: CALCIUM GLUCONATE; INOTROPE; INSULIN INFUSION; IV FLUIDS; MAGNESIUM SULFATE; NORADRENALINE; ORAL HYPOGLYCEMIC; VITAMIN D
• Patient Age: 54 YR
• Patient Sex: Female