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

Catalog Number	06368590190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys anti-tpo assay on a cobas 6000 e601 module.Initial result: 127 iu/ml.The customer noticed that the initial result was high and repeated the sample.On (b)(6) 2026: 1st repeat result: 50 iu/ml.2nd repeat result: 23 iu/ml (tested after calibration).On (b)(6) 2026, a new reagent pack was used: the original sample was re-tested: 3rd repeat result: <5 iu/ml.A new sample was drawn and tested, resulting in a value of <5 iu/ml.The repeat result of 23 iu/ml was deemed to be correct.
Additional Manufacturer Narrative
The e601 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The reagent pack was not calibrated on the date of the event.A daily calibration is required for the elecsys anti-tpo assay and daily qc for every reagent.After the calibration was performed, the reagent kit performed as expected.The product labeling states: "calibration frequency: perform calibration on all analyzers as follows: with every reagent kit calibration interval may be extended based on acceptable verification of calibration by the laboratory.Renewed calibration on all analyzers: daily: when using the same reagent kit on the analyzers as required: e.G.Quality control findings outside the defined limits quality control: for quality control, use precicontrol thyroab.In addition, other suitable control material can be used.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the investigation did not identify a product problem.The cause of the event was due to inappropriate reagent handling (no daily calibration).

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24250305
• Report Number: 1823260-2026-00369
• Device Sequence Number: 18556256
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 03/17/2026

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: 03/31/2026
• Device Catalogue Number: 06368590190
• Device Lot Number: 86800901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/17/2026
• 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