MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4 ELECSYS E2G 300 V2; TOTAL THYROXINE ASSAY

Catalog Number	09007741190
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Na.
Event or Problem Description
The initial reporter received a questionable t4 elecsys e2g 300 v2 result for one patient sample tested on a cobas e411 rack with serial number: (b)(4) compared to a vidas analyzer.The initial result was not reported outside of the laboratory.The result from the e 411 at 1:51 pm was 246.5 nmol/l with a data flag.The result from the vidas analyzer at 2:00 pm was 130.96 nmol/l.The vidas result was reportedly more consistent with the total thyroid profile of the patient.
Additional Manufacturer Narrative
The investigation is ongoing.Na.
Event or Problem Description
The initial reporter received a questionable t4 elecsys e2g 300 v2 result for one patient sample tested on a cobas e411 rack with serial number: (b)(4) compared to a vidas analyzer.The initial result was not reported outside of the laboratory.The result from the e 411 at 1:51 pm was 246.5 nmol/l with a data flag.The result from the vidas analyzer at 2:00 pm was 130.96 nmol/l.The vidas result was reportedly more consistent with the total thyroid profile of the patient.
Additional Manufacturer Narrative
Additional information was requested but not provided.The cause of the event could not be dertermined.

• Brand Name: T4 ELECSYS E2G 300 V2
• Common Device Name: TOTAL THYROXINE ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13569155
• Report Number: 1823260-2022-00467
• Device Sequence Number: 11792049
• Product Code: CDX
• UDI-Device Identifier: 07613336171660
• UDI-Public: 07613336171660
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 06/29/2022

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: 06/30/2022
• Device Catalogue Number: 09007741190
• Device Lot Number: 53112600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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