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

Catalog Number	07027885190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned thyroid results for 1 patient tested on a cobas e801 module compared to the beckman, abbott, siemens and wantai methods.Discrepant results were identified for elecsys t3 (t3), elecsys ft3 (ft3), elecsys t4 (t4), elecsys ft4 (ft4) and elecsys tsh (tsh).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 by the doctor as the patient had been taking methimazole.The customer suspects an interference affecting the roche results.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
The sample was requested for investigation but could not be provided.Since the sample was not available for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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: 15178036
• Report Number: 1823260-2022-02319
• Device Sequence Number: 6330047
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• 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
• Report Date (Section B): 08/05/2022

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 07027885190
• Device Lot Number: 57437101
• 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: 07/12/2022
• Initial Report FDA Received Date: 08/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METHIMAZOLE
• Patient Age: 19 YR
• Patient Sex: Female