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

Catalog Number	07026935190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) cleaned the probes and checked the probe and cleaning positions.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable roche diagnostics cobas elecsys anti-tpo results for 2 patient serum samples on a cobas e 801 module.On (b)(6) 2024, sample 1 had an initial anti-tpo result of 42.7 iu/ml.An aliquot of the sample was repeated on another e801 analyzer and the result was <9.00 iu/ml with flag.An aliquot sample was repeated on the original analyzer and the result was 9.96 iu/ml the original sample was also repeated on the original analyzer and the result was <9.00 iu/ml with flag.On (b)(6) 2024, sample 2 had an initial anti-tpo result of 42.0 iu/ml.The sample was repeated twice and the results were 10.7 iu/ml and 13.0 iu/ml.An aliquot of the sample was also tested and the result was 11.2 iu/ml.

• 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: 19528769
• Report Number: 1823260-2024-01756
• Device Sequence Number: 15355078
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 07/22/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 07026935190
• Device Lot Number: 76913801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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