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

Catalog Number	08828679190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys procalcitonin v2 results for 1 patient sample on a cobas 8000 core unit.On (b)(6) 2023, the initial result was greater than 100 ng/ml.The sample was repeated and gave a result of greater than 100 ng/ml.On (b)(6) 2023, a 1:3 dilution was made from the initial refrigerated sample and the result was 45 ng/ml.The refrigerated original sample was repeated again and the result was 48.4 ng/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyze serial number is (b)(6).It was found that the stability of the measured samples is 24 hours at 20 to 25 degrees c and 48 hours at 2 to degrees c.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the information provided, the root cause of the event was found to be consistent with the exceeded storage time of the sample for the given temperature.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17671494
• Report Number: 1823260-2023-02864
• Device Sequence Number: 6208309
• Product Code: PRI
• UDI-Device Identifier: 07613336166642
• UDI-Public: 07613336166642
• Combination Product (Y/N): Y
• 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): 11/08/2023

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 Catalogue Number: 08828679190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/08/2023
• 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