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 Problems Polymyositis (1992); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

A sample was requested for investigation.

Event Description

The initial reporter received questionable elecsys tsh assay and elecsys ft4 iii results for one patient on 5 different samples with the cobas e 801 module serial number (b)(4).Sample id (b)(6): on (b)(6) 2021, the tsh result was 0.16 uiu/ml.The ft4 result was 7.77 ng/dl.Sample id (b)(6): on (b)(6) 2021, the tsh result was 0.132 uiu/ml.The ft4 result was 7.77 ng/dl.Sample id (b)(6): on (b)(6) 2021, the tsh result was 0.493 uiu/ml.The ft4 result was 7.77 ng/dl.Sample id (b)(6): on (b)(6) 2021, the tsh result was 0.493 uiu/ml.The ft4 result was 4.75 ng/dl.Sample id (b)(6): on (b)(6) 2021, the tsh result was 16.1 uiu/ml.The ft4 result was 1.44 ng/dl.On (b)(6) 2021, the tsh result on 1:20 dilution was 93.9 uiu/ml.The ft4 result was 4.50 ng/dl.On an unknown date at another hospital, the tsh result was >100 uiu/ml.The ft4 result was not provided.On an unknown date at a second hospital, the tsh result was around 90 uiu/ml.The ft4 result was not provided.On an unknown date at a reference laboratory, the tsh result was >100 uiu/ml.The ft4 result was not provided.The questionable results were reported outside of the laboratory and questioned by the endocrinologist.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.

Manufacturer Narrative

The following additional information has been received.The patient had a medical history of hypothyroidism since 2002 and was suspected of grave's disease.The patient had been taken off euthyrox on an unknown date and prescribed tirodril, prednisone, and propanolol for hyperthyroidism allegedly due to the tsh, ft4, and ft3 results.The subsequent results from the patient were not correlating to the treatment and therefore found to be incorrect.Under the suspicion of an analytical interference, the patient was then suspected to have severe hypothyroidism and treatment for hypothyroidism was started again.The patient was treated with tirodril from (b)(6) 2021 to (b)(6) 2021.Currently, tirodril and propanolol are removed and the patient has been prescribed euthyrox again.After starting treatment for hypothyroidism, the patient was admitted to the hospital on (b)(6) 2021 for allegedly presenting with acute and severe myositis that they suspect may be due to hypothyroidism.The patient was discharged on (b)(6) 2021.The patient is currently at home being monitored.Additional discrepant results provided by the customer are as follows: on (b)(6) 2021 with sample id (b)(6) from the customer site, the patient had a tsh of 21.70, an ft4 of 0.76, and an ft3 of 4.54.On (b)(6) 2021 with sample id (b)(6) from a hospital with a siemens analyzer, the patient had a tsh of 21.70, an ft4 of 0.45, and an ft3 of 1.3.From the customer site, the patient had a tsh of 26.50, an ft4 of 0.98, and an ft3 of 4.59.On (b)(6) 2021 with sample id (b)(6) from the hospital with a siemens analyzer, the patient had a tsh of 107, an ft4 of 0.46, and an ft3 of 1.4.The units of measure were not provided.The patient samples were returned for investigation.An interfering factor against the streptavidin component of the reagent has been confirmed within the sample, which leads to elevated elecsys ft3 iii and ft4 iii results and suppressed tsh concentrations.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." a general product problem can be excluded.Medwatch fields a2, a3, b1, b2, b6, b7, and d10 have been updated.Refer to the medwatch with a1 patient identifier (b)(6) for the tsh assay and (b)(6) for the ft3 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
• 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: 12591834
• MDR Text Key: 275232774
• Report Number: 1823260-2021-02936
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: ASKU
• 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
• Report Date: 11/05/2021

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 G3
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 11/07/2021
• 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
• Treatment: EUTHYROX; PREDNISONE; PROPANOLOL; TIRODRIL
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female