MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 08429324190

Device Problem Low Test Results (2458)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The tsh reagent lot number was 76392200 with an expiration date of 30-jun-2024.The ft3 iii reagent lot number was 68665600 with an expiration date of 30-apr-2024.The a-tshr reagent lot number and expiration date were not provided.The e601 module serial number was (b)(6).Three samples were received for investigation on 21-mar-2024.The first sample was the one collected on (b)(6) 2024 for serum while the other two samples were the ones collected on (b)(6) 2024 for serum and plasma.The customer suspected a possible interfering factor.The investigation is ongoing.

Event Description

We received an allegation about results inconsistent with the patient's health condition when tested with elecsys tsh assay, elecsys ft3 g3 (ft3 iii) assay, elecsys ft4 g4 (ft4 iv) assay, and elecsys anti-tshr (a-tshr) assay on a cobas 6000 e601 immunoassay analyzer compared to non-roche analyzers (abbott alinity/architect and siemens dimension).This medwatch will apply to the ft4 iv assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the tsh assay, to the medwatch with a1.Patient identifier pt (b)(6) for information related to the ft3 iii assay, and to the medwatch with a1.Patient identifier pt (b)(6) for information related to the a-tshr assay.On (b)(6) 2024 the patient had a tsh result of 0.17 uiu/ml (the reference range: 0.27 - 4.20 uiu/ml).On (b)(6) 2024 a new serum sample was tested and the patient had a tsh result of 0.179 uiu/ml.This tsh result was interpreted as hyperthyroidism.Ft3 iii result: 9.53 pg/ml (the reference range: 2.00 - 4.40 pg/ml).Ft4 iv result: 3.95 ng/dl (the reference range: 0.93 - 1.70 ng/dl).A-tshr result: 37.8 iu/l (the reference range: < 1.75 iu/l).Another new sample was drawn from the patient and tested on the same e601.All results were identical to the initial results.Both the physician and the patient questioned the tsh results as they did not match the patient's clinical diagnosis.The sample that resulted in a tsh result of 0.179 uiu/ml, was re-tested on non-roche analyzers on the same day.Tsh result: 1.262 uiu/ml (tested on abbott: alinity/architect).Tsh result: 0.945 uiu/ml (tested on siemens dimension).These tsh results were interpreted to be within the range.On (b)(6) 2024 a new serum and plasma sample was drawn.The sample was tested on a roche cobas analyzer and obtained the following results.Tsh result: 0.107 uui/ml.Ft3 iii result: 9.52 pg/ml.Ft4 iv result: > 7.77 ng/dl.The sample was also tested on abbott alinity analyzer and obtained the following results.Tsh result: 1.121 uum/ml.Ft3 result: 3.08 pg/ml.Ft4 result: 1.05 ng/dl.The samples were then tested with dilutions 1:5 and 1:10 and the results were similar to the undiluted results.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18989167
• MDR Text Key: 338755252
• Report Number: 1823260-2024-00925
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K961491
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08429324190
• Device Lot Number: 76723500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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 Sex: Female