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

Catalog Number	08828679190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys brahms pct assay on a cobas e 801 analytical unit.The sample initially resulted in a pct value of 0.16 ng/ml.The result was reported outside of the laboratory and questioned.The sample was repeated resulting in a pct value of 28.9 ng/ml.A new sample draw of the patient resulted in a pct value of 27.3 ng/ml.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2023, and the quality controls results do not indicate a general reagent issue.Upon review of the alarm trace, no general instrument issue was detected.It was determined that the tip of the sample probe had a crystal, indicating inadequate daily sample probe manual cleaning by the operator.The crystals could be contaminating the aspirated sample but would not cause the observed event.The investigation could not identify a product problem.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 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16454548
• Report Number: 1823260-2023-00617
• Device Sequence Number: 5875597
• Product Code: PRI
• UDI-Device Identifier: 07613336166642
• UDI-Public: 07613336166642
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 02/28/2023

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: 08/31/2023
• Device Catalogue Number: 08828679190
• Device Lot Number: 59498801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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