MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS BRAHMS PCT; PROCALCITONIN ASSAY

Catalog Number	08828679190
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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).Sample material was requested for investigation.
Event or Problem Description
The initial reporter questioned the results for 1 patient tested for elecsys brahms pct (pct) on a cobas e 402 analytical unit.The patient was tested daily with results consistently around 2 ng/ml (examples provided were 1.89 ng/ml and 2.11 ng/ml).The results were "always repeatable." the following specific results were provided: on (b)(6) 2025, the result was 2.22 ng/ml.On (b)(6) 2025, the result was 2.49 ng/ml.On (b)(6) 2025, the result was 1.94 ng/ml.On (b)(6) 2025, the result was 2.08 ng/ml.On (b)(6) 2025, the result was 2.18 ng/ml.On (b)(6) 2025, the result was 1.87 ng/ml.On (b)(6) 2025, the result was 2.09 ng/ml.On (b)(6) 2025, the result was 2.09 ng/ml.On (b)(6) 2025, the result was 2.08 ng/ml.On (b)(6) 2025, the result was 2.21 ng/ml.On (b)(6) 2025, the result was 1.91 ng/ml.The patient had been initially tested by a mindray instrument, which produced similar results.A sample from the patient was tested at an external laboratory using the vidas method, and the result was also "positive" (1.27 ng/ml).The pct results are in question as no other test results suggest sepsis, the patient is well with no fever, and the crp result was "negative." the customer suspects an interference affecting the results.
Additional Manufacturer Narrative
Section d4 was updated.The calibration signals were very high compared to the expected signal counts.The sample was received for investigation on 30-jul-2025, where it was tested on a cobas e402: pct result without hbt treatment: 1.33 ng/ml.Pct result with hbt treatment: 1.31 ng/ml.No reagent-specific issue could be identified.The result was considered a true value.The investigation did not identify a product problem.The reagent meets the specifications.

• Brand Name: ELECSYS BRAHMS PCT
• Common Device Name: PROCALCITONIN ASSAY
• 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: 22663228
• Report Number: 1823260-2025-02340
• Device Sequence Number: 14378037
• Product Code: PRI
• UDI-Device Identifier: 07613336166642
• UDI-Public: 07613336166642
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192815
• 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): 09/24/2025

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: 07/31/2026
• Device Catalogue Number: 08828679190
• Device Lot Number: 828429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METHADONE
• Patient Sex: Male