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	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The customer performed a comparison study using four patient samples.The patient samples were run on the analyzer and the mindray instrument.The customer stated that the results were good.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable roche diagnostics cobas elecsys anti-tpo and roche diagnostics elecsys anti-tg results from one patient sample tested on the cobas e 801 analytical unit.This mdr is for the anti-tpo assay.Please refer to mdr with a1.Patient identifier (b)(6) for the anti-tg assay.The reporter stated that the differences between the anti-tg and anti-tpo results from the analyzer and the mindray instrument were too large.The initial results were not reported outside of the laboratory because the results did not match the patient's clinical diagnosis.The initial anti-tpo result from the analyzer was 152.2 iu/ml.The repeat result from the mindray instrument was 269.29 iu/ml.The reference ranges were requested but not provided.
Additional Manufacturer Narrative
The measured autoantibodies in a patient¿s sample can vary depending on the testing procedure used.Autoantibody values from different testing procedures cannot be directly compared.The reactivity of autoantibodies in different tests varies due to the use of different assay formats, detection antibodies, antigen formulations, and incubation times.The investigation did 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 46250-0457
• MDR Report Key: 17919239
• Report Number: 1823260-2023-03272
• Device Sequence Number: 16846674
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K051890NA
• 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): 11/29/2023

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 Catalogue Number: 07026935190
• Device Lot Number: ASKU
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/05/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/29/2023
• 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