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

Catalog Number 08828679190

Device Problem Non Reproducible Results (4029)

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

Event Date 08/04/2023

Event Type  malfunction  

Event 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.

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.

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
• 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: 17671494
• MDR Text Key: 322524311
• Report Number: 1823260-2023-02864
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 07613336166642
• UDI-Public: 07613336166642
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 08828679190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1