MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; TOTAL THYROXINE ASSAY

Catalog Number 09007741190

Device Problem Non Reproducible Results (4029)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas 6000 e 601 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable t4 elecsys , elecsys t3, elecsys tsh assay results from three patient samples tested on the cobas 6000 e601 module.This medwatch is for the t4 assay.Please refer to: mdr with a1.Patient identifier (b)(6) for the tsh assay.Mdr with a1.Patient identifier (b)(6) for the t3 assay.The initial results were not reported outside of the laboratory.The results did not match the patients' clinical records prompting the rerun of the patient samples.Please refer to the attachment (b)(6) for the table containing the highlighted questionable results.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The field service engineer replaced the measuring cells and the sipper seals.He performed a precision check with successful results.The investigation noted that the observed discrepancies appeared to be erratic and did not follow a specific pattern.The investigation reviewed the alarm trace; a few sipper alarms were noted.The investigation's reagent support checked the qc and calibration data; a reagent-related cause was not identified.The investigation determined that the event was caused by the seal - consistent with a leakage at the sipper.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS T4
• Type of Device: TOTAL THYROXINE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18442665
• MDR Text Key: 332607936
• Report Number: 1823260-2024-00022
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171660
• UDI-Public: 07613336171660
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: K060373
• 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: 02/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 09007741190
• Device Lot Number: 71166302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/22/2024
• 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