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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The customer¿s e801 module serial number was (b)(6).The e801 module serial number used at the investigation site was (b)(6).The e411 analyzer serial number used at the investigation site was (b)(6).The ft4 iv reagent lot number used with the e411 analyzer was 663936 with an expiration date of 31-oct-2023.The ft4 iii reagent lot number used with the e801 module at the investigation site was 700216 with an expiration date of 31-jan-2024.The ft4 iv reagent lot number used with the e801 module at the investigation site was 670634 with an expiration date of 30-nov-2023.The investigation is ongoing.

Event Description

The initial reporter questioned the results for 4 patient samples tested for elecsys tsh (tsh), elecsys ft4 iv (ft4 iv) and elecsys ft3 iii (ft3 iii).The results were reported outside of the laboratory where additional testing was requested.The samples were submitted for investigation where discrepant results were identified for tsh, ft4 and ft3 iii between the customer¿s e801 module, an e801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the abbott architect method.This medwatch will cover ft4.Refer to medwatch with a1 patient identifier (b)(6) for information on the tsh results and medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.Refer to the attached for the patient results.

Manufacturer Narrative

Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.From the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.

• 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: 17566668
• MDR Text Key: 321368948
• Report Number: 1823260-2023-02680
• 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: 09/07/2023

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/07/2023
• 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