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

Catalog Number 07027885190

Device Problem High Test Results (2457)

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

Event Date 07/09/2022

Event Type  malfunction  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 305000734
• Report Number: 1823260-2022-02319
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (y/n): N
• 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
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/05/2022
• 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
• Treatment: METHIMAZOLE
• Patient Age: 19 YR
• Patient Sex: Female