MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TG; THYROID AUTOANTIBODY TEST SYSTEM

Catalog Number	07026919190
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable anti-tg elecsys e2g result from the cobas e 801 module.The result from the cobas e 801 module was reportedly 398 iu/ml.On 01-sep-2023, using the beckman coulter access dxl method, the result was reportedly 3.4 iu/ml.The results were reported outside the laboratory and the physician questioned how to compare the two results and how to interpret them.It is not known which result was believed to be correct.A new sample was collected from the patient on a later unknown date and the anti-tg result on the cobas e 801 module was reportedly the same.No specific data was provided.
Additional Manufacturer Narrative
The field service engineer found the incorrect test was ordered when the new sample collected from the patient was sent to a reference lab for testing.He provided documentation to the customer regarding the two assays.The provided calibration and qc data were acceptable.The customer's centrifugation time may be shorter than recommended and the spin speed may be faster than recommended.Correct pre-analytic sample handling is within the customer's responsibility.The analyzer alarm trace contained sample foam detection, sample clot detection, abnormal aspiration (sample probe a/b), abnormal sample aspiration, and abnormal aspiration (sample probe) errors.These are indicators of possible poor sample quality.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-TG
• Common Device Name: THYROID AUTOANTIBODY TEST SYSTEM
• 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: 17912373
• Report Number: 1823260-2023-03256
• Device Sequence Number: 6636306
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 03/31/2024
• Device Catalogue Number: 07026919190
• Device Lot Number: 69848101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic