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

Model Number 57400

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

A nova biomedical field service technician visited the user facility to service the analyzer.They determined that the issue was caused by a calibrator cartridge that was not properly prepared prior to use.The field service technician confirmed that replacing the calibrator cartridge resolved the issue and returned the analyzer to service.

Event Description

A user facility reported a nova biomedical prime plus analyzer that showed discrepant creatinine results when compared to their reference analyzer.There was no patient 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: 9344973
• MDR Text Key: 178739715
• Report Number: 1219029-2019-00068
• 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: K180428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• 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