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

Catalog Number	06368590190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e411 analyzer serial number is (b)(6).The field service engineer checked the fluid path.The pinch valve tubing and sample pipettor tubing were replaced.The customer repeated patient samples and the results were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable for a total of 12 patient samples tested with elecsys anti-tpo on a cobas e411 disk.Examples were provided for three patient samples with discrepant anti-tpo results.The first sample initially resulted in an anti-tpo value of > 600 iu/ml with a data flag and it repeated as 16.72 iu/ml.The second sample initially resulted in an anti-tpo value of 162 iu/ml and it repeated as 74.97 iu/ml.The third sample initially resulted in an anti-tpo value of 49.7 iu/ml and it repeated as 16 iu/ml.
Additional Manufacturer Narrative
The calibration signals were lower than expected, but this had no influence on the issue.Quality controls were acceptable.A general reagent issue can be ruled out.Isolated non-reproducible results do not represent a general malfunction of the assay.Upon review of the alarm trace, no relevant alarms were observed.The instrument appeared dirty.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 20599173
• Report Number: 1823260-2024-03176
• Device Sequence Number: 12962690
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K051890
• 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): 11/08/2024

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: 06368590190
• Device Lot Number: 784656
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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 Sex: Unknown