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

Model Number FT4 IV

Device Problem High Test Results (2457)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys ft3 iii and elecsys ft4 iv assay results for 1 patient sample on a cobas e 801 module.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.The doctor questioned the roche results which prompted the customer to repeat the sample on a competitor analyzer.The sample had a roche ft3 result of 8.20 pmol/l and a roche ft4 result of 1.98 ng/dl.The roche ft3 reference range is 3.1 - 6.8 pmol/l.The roche ft4 reference range is 0.92 - 1.68 ng/dl.The sample had an abbott ft3 result of 4.58 pmol/l and an abbott ft4 result of 11.2 pmol/l.The abbott ft3 reference range is 2.43 - 6.00 pmol/l.The abbott ft4 reference range is 9.01 - 19.05 pmol/l.

Manufacturer Narrative

The analyzer serial number is (b)(6).The sample was requested for investigation.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: 19153802
• MDR Text Key: 341576324
• Report Number: 1823260-2024-01223
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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
• Report Date: 04/22/2024

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 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 74937202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1