MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STAT PROFILE PRIME CCS COMP; BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER

Model Number PRIME CCS COMP

Device Problem Low Test Results (2458)

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

Event Date 02/26/2022

Event Type  malfunction  

Manufacturer Narrative

A dhr review was performed on the prime analyzer.The analyzer met all specifications and no discrepancies were found.

Event Description

The customer reported discrepant results on prime analyzer (b)(4) for pco2.The clinician questioned the results and ran the sample again on a different prime analyzer.This second test was closer to the patient history and central lab data.There was no patient harm or intervention reported.

• Brand Name: NOVA STAT PROFILE PRIME CCS COMP
• Type of Device: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13964673
• MDR Text Key: 288278533
• Report Number: 1219029-2022-00030
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480528573
• UDI-Public: 00385480528573
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131703
• 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
• Report Date: 03/31/2022

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 Model Number: PRIME CCS COMP
• Device Catalogue Number: 52857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1