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

Catalog Number	07026935190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys anti-tpo result from the cobas e 402 analytical unit.The initial result was > test 600 kiu/i, and the 1st repeat result was > test 600 kiu/i.The 2nd repeat result with a manual dilution of 1:5 was 14.3 kiu/i.The 3rd repeat result with a manual dilution of 1:5 was 13.5 kiu/i.The 4th repeat result with a manual dilution of 1:1 was 117 kiu/i.
Additional Manufacturer Narrative
The cobas e 402 analytical unit serial number is (b)(6).The diluent being used by the customer was used for approximately 20 weeks, exceeding the lifetime of the diluent.The investigation is ongoing.
Additional Manufacturer Narrative
The initial value reported of 13.5 kiu/i was not correct.Additional values of 13.4 kiu/i with a dilution of 1:5 and 13.3 kiu/i on 30-jan-2025 with a manual dilution of 1:5 were provided.On (b)(6) 2025, the customer repeated the sample using a new diluent and the results were 12.3 kiu/i with a manual dilution of 1:5.In another run, the result was 20.7 kiu/i with a manual dilution of 1:5.The investigation is ongoing.
Additional Manufacturer Narrative
Two samples were analyzed to verify the values of elecsys anti-tpo.The following were results determined with a cobas e 801: anti-tpo: 363 iu/ml ¿ above cutoff value of 34 iu/ml.After 1:2 dilution: 56 iu/ml (calculated final concentration).After 1:5 dilution: 12 iu/ml (calculated final concentration).After further investigation of the sample, an assay interfering factor was detected by changing concentrations.This interference causes the falsely elevated values elecsys® anti-tpo assays.With dilution 1:2, the impact of the interfering factor gets smaller leading to smaller, but still falsely elevated results.An interfering factor, causing a falsely increased value with elecsys anti-tpo, was detected in the sample.This is a known interference clearly disclaimed in the method sheet.Disclaimer from method sheet: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." a general product problem can be excluded.

• 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: 21431933
• Report Number: 1823260-2025-00504
• Device Sequence Number: 4606600
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 05/21/2025

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: 03/31/2025
• Device Catalogue Number: 07026935190
• Device Lot Number: 80820201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 05/20/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/24/2025; 05/21/2025
• 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