MAUDE Adverse Event Report: Roche Diagnostics Elecsys BRAHMS PCT; Procalcitonin Assay

Catalog Number	08828644190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys brahms pct assay result for one patient sample tested on the cobas 6000 e601 module.Initial analysis of the patient sample yielded 2.4 ng/ml.Repeat analysis yielded 0.09 ng/ml.The repeat result was reported, as the patient's previous result was 0.41 ng/ml.
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number is (b)(6).The customer verified their system settings and reported no further issues.The cause of the event could not be determined.

• Brand Name: Elecsys BRAHMS PCT
• Common Device Name: Procalcitonin Assay
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50865648
• Report Number: 1823260-2026-03896
• Device Sequence Number: 9425338
• Product Code: PRI
• UDI-Device Identifier: 07613336166635
• UDI-Public: 07613336166635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/23/2026
• 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