MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT PROFILE PRIME PLUS ANALYZER SYSTEM; BLOOD GAS ANALYZER

Model Number 57400

Device Problem Low Test Results (2458)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

A nova biomedical service technician inspected the analyzer on-site, and found a slightly bent probe to be a possible cause of the low creatinine readings.The nova biomedical service technician reportedly straightened the probe to resolve the issue.The service technician reportedly ran 11 comparison samples to other prime plus analyzers, all of which tested in range.

Event Description

A user facility reported a prime plus analyzer that reportedly gave a low creatinine result when compared to other reference methods.There was no patient injury, harm, or medical intervention reported.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• Manufacturer Contact: mariya cesnulevicius ; 200 prospect st.; waltham, MA 02454-3654 ; 7816473700
• MDR Report Key: 9233229
• MDR Text Key: 168205651
• Report Number: 1219029-2019-00055
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1