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

Catalog Number	07026935190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-tpo results for 1 patient sample on a cobas 8000 e 801 module.The initial result was >600 iu/ml.A manual dilution (1:5) was performed and the result was approximately 50 iu/ml.It was reported that a dilution was performed several times and the result was always approximately 50 iu/ml.A second test tube of the same sample was tested.The initial result was (1:1) >600 iu/ml.The result with a 1:5 dilution was 58.5 iu/ml.The result with a 1:2 dilution was 484 iu/ml.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The alleged sample is no longer available.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the different sample values generated with dilution and without dilution relate to the nature of the analyte detected with the anti-tpo assay.Auto-antibodies can cause non-linear effects when they are diluted.This limitation is covered in product labeling.An overall reagent issue can be excluded.The investigation could not identify a product problem.

• 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: 18779634
• Report Number: 1823260-2024-00547
• Device Sequence Number: 12857669
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 03/13/2024

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: 04/30/2024
• Device Catalogue Number: 07026935190
• Device Lot Number: 74625401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/13/2024
• 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