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

Catalog Number	06368590190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient serum/plasma sample tested with elecsys anti-tpo assay on a cobas e411 immunoassay analyzer (rack system).Initial result: >600.0 iu/ml (accompanied by a data flag and considered above the measuring range).The customer questioned the initial result as it did not match the patient's previous results.The sample was then repeated.1st repeat result: 10.22 iu/ml obtained with a manual dilution of 1:5 and, therefore, multiplied by the factor 5 the final result would be 51.1 iu/ml.2nd repeat result: 18.76 iu/ml (no dilution).No questionable result was reported outside the laboratory.The 2nd repeat result was deemed to be correct.
Additional Manufacturer Narrative
The anti-tpo reagent expiration date was not provided.The cobas e411 rack serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 was updated.The calibration was not performed daily as recommended.The product labeling states: "renewed calibration on all analyzers: daily: when using the same reagent kit on the analyzers." the provided qc screenshot showed that the qc was within ranges, but the measurement date/time and the actual numeric results were not shown.The provided pre-analytical showed that the customer used 13 mm diameter tubes but did not use the required rack adapters for them.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 19840644
• Report Number: 1823260-2024-02177
• Device Sequence Number: 20775747
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• 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): 09/12/2024

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: 01/31/2025
• Device Catalogue Number: 06368590190
• Device Lot Number: 769146
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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