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

Catalog Number	08828679190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable elecsys brahms pct (procalcitonin) results for one patient sample tested on two cobas e 801 analytical unit analyzers.The procalcitonin results are inconsistent with the patient's clinical status, other test results, and the patient's background.Prior to undergoing dialysis, a sample was collected from the patient and tested on the customer's e801 analyzer, resulting in a procalcitonin value of > 100 ng/ml.This sample had a crp value of 3.23 mg/dl and a white blood cell count of 6602/ul, so there were no signs of infection in the patient.The doctor questioned the procalcitonin value.The sample was diluted times 5 and repeated on the customer's e801 analyzer, resulting in a raw procalcitonin value of 16.2 ng/ml.The final value when accounting for the dilution factor is 81.0 ng/ml.The sample (b)(6) 2026.The repeat procalcitonin result was > 100 ng/ml.The sample was diluted 1:5 and repeated on this analyzer, resulting in a value of 79.5 ng/ml.
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer is (b)(6).The serial number of the (b)(6) analyzer used for investigation was requested, but not provided.The patient sample was requested for investigation.The investigation is ongoing.

• 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: 24731819
• Report Number: 1823260-2026-01165
• Device Sequence Number: 9215055
• Product Code: PRI
• UDI-Device Identifier: 07613336166642
• UDI-Public: 07613336166642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/06/2026

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: 08828679190
• Device Lot Number: 87572901
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/06/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CEFAZOLIN
• Patient Age: 78 YR
• Patient Sex: Female