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

Catalog Number 07026935190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 325478730
• Report Number: 1823260-2023-03272
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K051890NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026935190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1