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

Catalog Number	12017709122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys t3 (t3), elecsys ft3 (ft3), elecsys t4 (t4), elecsys ft4 (ft4) and elecsys tsh (tsh) on a cobas 8000 e 602 module compared to the siemens and autobio methods.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the t3 results, medwatch with a1 patient identifier (b)(6) for information on the ft3 results, medwatch with a1 patient identifier (b)(6) for information on the ft4 results and medwatch with a1 patient identifier (b)(6) for information on the tsh results.Refer to the attached data for the patient results.The roche results were reported outside of the laboratory where they were questioned as they did not correspond to the patient¿s clinical picture.The sample was repeated by 2 other methods.The customer suspects an interference affecting the roche results.The e602 module serial number was (b)(4).
Additional Manufacturer Narrative
The reagent material number was provided by the investigation.Section d4, catalog number, and udi# were updated.Section g4, 510k was updated.The sample was submitted for investigation.The customer's results were reproduced during the investigation.Interference testing was performed and no interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15349985
• Report Number: 1823260-2022-02715
• Device Sequence Number: 14832393
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/06/2022

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 Catalogue Number: 12017709122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/06/2022
• 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