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	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).On 16-aug-2024 qc was outside of the acceptable range on the same reagent lot.The customer recalibrated twice using a new reagent pack from the same lot, reconstituted new qc material and qc was still outside of the acceptable range.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned high results for "several" patient samples tested for elecsys anti-tpo (anti-tpo) on a cobas e 411 analyzer (disk system).Following the high results, the customer recalibrated the reagent and repeated the patient samples and the results were not reproducible.Examples of discrepant results were provided for 4 patient samples.Patient 1 initial result was >600 iu/ml with a data flag.The repeat result was 180.0 iu/ml.Patient 2 initial result was 449.5 iu/ml.The repeat result was 16.94 iu/ml.Patient 3 initial result was 492.0 iu/ml.The repeat result was 14.41 iu/ml.Patient 4 initial result was 144.8 iu/ml.The repeat result was 13.09 iu/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration signals were within expectations, however, the customer does not calibrate the reagent daily.Product labeling states: "renewed calibration on all analyzers: daily: when using the same reagent kit on the analyzers".Qc data was imprecise due to the missing daily calibration.The investigation determined the event was consistent with a reagent handling issue (not calibrating the reagent daily).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
• MDR Report Key: 20157935
• Report Number: 1823260-2024-02581
• Device Sequence Number: 4248714
• 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): 10/15/2024

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: 03/31/2025
• Device Catalogue Number: 06368590190
• Device Lot Number: 78465601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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