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

Catalog Number 09318712190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2023

Event Type  malfunction  

Event Description

The initial reporter questioned high results not corresponding to the clinical picture for 1 patient tested for elecsys brahms pct (pct) on a cobas e 601 module.The patient reportedly had "very high" pct results for "several days" (e.G.90 ng/ml).Multiple samples were obtained from the patient since "mid-october" and the results were greater than 25 ng/ml.The samples were not repeated on other instruments.The pct results decreased since.On (b)(6) 2023 the result was 63 ng/ml.On (b)(6) 2023 the result was 47 ng/ml.On (b)(6) 23023 the result was 34 ng/ml.

Manufacturer Narrative

The e601 module serial number was (b)(6).Calibration and qc were acceptable.It was noted that pct is produced in the c-cells of the thyroid and is known to be elevated in the absence of infection in patients with thyroid disease or dysfunction.The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS BRAHMS PCT
• Type of Device: 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18256723
• MDR Text Key: 329609208
• Report Number: 1823260-2023-03832
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K192815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 09318712190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EUTHYROX.