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

Catalog Number	09007784190
Medical Device Problem Codes	Incorrect Measurement (1383); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Sections d4, catalog number, and udi were updated.

• Brand Name: ELECSYS T4
• Common Device Name: 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
• Report Number: 1823260-2023-03885
• Device Sequence Number: 17619649
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K961490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 09007784190
• Device Lot Number: 711668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 03/13/2024; 04/15/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/20/2024; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown