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

Catalog Number 09043284190

Device Problem High Test Results (2457)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii), and elecsys ft4 iv (ft4 iv) on a cobas e 801 analytical unit compared to a competitor method.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.On (b)(6) 2024 the ft3 iii result from the e801 analyzer was 22.1 pg/ml.On (b)(6) 2024 the ft4 iv result from the e801 analyzer was 6.68 ng/dl.The patient was moved to a different hospital.On (b)(6) 2024 the thyroid results from the other hospital were "normal." due to the "normal" results from the other hospital, the customer sent the patient sample to an external laboratory for testing by a competitor method.On (b)(6) 2024 the ft3 result from the competitor method was 3.7 pg/ml.On (b)(6) 2024 the ft4 result from the competitor method was 1.5 ng/dl.

Manufacturer Narrative

The e801 analyzer serial number was (b)(6).The competitor method was tosoa aia-600.The sample was requested for investigation.

Manufacturer Narrative

A new sample was obtained from the patient on (b)(6) 2024.The results were similar to the initial results from (b)(6) 2024.The sample was submitted for investigation and discrepant results were identified for ft3 iii and ft4 iv between the customer's e801 analyzer, an e801 analyzer used at the investigation site, an e411 analyzer used at the investigation site, and the abbott architect method.See the attached data for the patient results.The e801 analyzer used at the investigation site was (b)(6).The e411 analyzer used at the investigation site was (b)(6).The ft3 iii v2 reagent lot number used with the e411 analyzer was 686656 with an expiration date of 31-apr-2024.The ft3 iii v2 reagent lot number used with the e801 analyzer was 737314 with an expiration date of 30-nov-2024.The ft4 iv reagent lot number used at the investigation site was 724974 with an expiration date of 31-may-2024.The investigation is ongoing.

• 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
• MDR Report Key: 18817621
• MDR Text Key: 336737445
• Report Number: 1823260-2024-00615
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K220456
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09043284190
• Device Lot Number: 724974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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
• Treatment: BISOPROLOL FUMARATE; EMPAGLIFLOZIN; RIVAROXABAN