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

Catalog Number	08828644190
Medical Device Problem Codes	Incorrect Measurement (1383); 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	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys brahms pct results from the cobas 6000 e601 module.The initial result was >100 ng/ml.The physician requested manual dilution, and the customer performed a 1:4 manual dilution.The result was 15 ng/ml (x4=60 ng/ml).The customer performed another 1:2 manual dilution of the original sample, producing a result of 52 ng/ml.The customer did not know which result was correct.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause.A general reagent or analyzer problem was not present, because the qc prior to the event was within ranges.

• 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: 23942961
• Report Number: 1823260-2026-00002
• Device Sequence Number: 7946478
• Product Code: PRI
• UDI-Device Identifier: 07613336166635
• UDI-Public: 07613336166635
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Catalogue Number: 08828644190
• Device Lot Number: 864044
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/09/2026
• 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