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

Catalog Number 09007784190

Device Problems Incorrect Measurement (1383); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The e801 analyzer serial number was (b)(6).The customer noted the issue started when the stand-by reagent kit was switched.

Event Description

The initial reporter complained of discrepant results for 7 patient samples tested for elecsys t4 (t4) on a cobas e 801 analytical unit.The initial result for all 7 patient samples was >24.9 ug/dl with a data flag.Patient 1 repeat result was 5.97 ug/dl.Patient 2 repeat result was 5.55 ug/dl.Patient 3 repeat result was 3.91 ug/dl.Patient 4 repeat result was 4.16 ug/dl.Patient 5 repeat result was 8.74 ug/dl.Patient 6 repeat result was 5.65 ug/dl.Patient 7 repeat result was 5.10 ug/dl.

Manufacturer Narrative

The customer did not perform qc on the reagent pack before use.Product labeling states: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." the investigation determined the event was due to a reagent handling issue at the customer site.The investigation did not identify a product problem.

Manufacturer Narrative

Sections d4, catalog number, and udi were updated.

• Brand Name: ELECSYS T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 18277792
• MDR Text Key: 330817583
• Report Number: 1823260-2023-03885
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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,Followup
• Report Date: 04/18/2024

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 Catalogue Number: 09007784190
• Device Lot Number: 711668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/13/2024; 04/15/2024
• Supplement Dates FDA Received: 03/20/2024; 04/18/2024
• 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