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 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e801 immunoanalyzer serial number was (b)(6).Investigation is ongoing.

Event Description

We received an allegation about a suspected interference for 1 patient's sample tested with elecsys ft4 iv assay and discrepant results for the same patient's sample tested with elecsys ft3 iii assay on a cobas e801 immunoassay analyzer when compared to non-roche platforms (abbott and siemens).This medwatch will apply to the ft4 iv assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 iii assay.Ft4 iv results: initial result: more than 99 pmol/l.1st repeat result: 18.8 pmol/l (tested on siemens).2nd repeat result: 12.4 pmol/l (tested on abbott).Ft3 iii results: initial result: 13.3 pmol/l.1st repeat result: 6.2 pmol/l (tested on siemens).2nd repeat result: 4.2 pmol/l (tested on abbott).The questionable result of ft4 iv was not reported outside the laboratory as it was considered unbelievable.

Manufacturer Narrative

As no sample material could be provided, further investigation was not possible.A specific root cause could not be determined.

• 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: 17603291
• MDR Text Key: 321738830
• Report Number: 1823260-2023-02736
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 09/15/2023

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 Catalogue Number: 09043284190
• Device Lot Number: 670634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/15/2023
• 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