MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number PRIME PLUS

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

The present problem with creatinine testing after installation of new bun/creatinine sensor cartridges has occurred on a regular basis since we acquired the nova stat profile prime plus instruments, and has occurred on both instruments.The problem always occurs after installation of a new bun/creatinine cartridge, however, bias trends for patient results vary; patient results may be 50% above or below expected concentrations.The problem has occurred among multiple lots and is not lot-specific; within one lot there may be only a single cartridge that produces unacceptable patient results upon installation.The occurrence seems to be random in frequency (1-3 total occurrences per year).In all instances, qc does not indicate unacceptable instrument performance.Identification of creatinine problems only occurs through evaluation of patient specimens.

• Brand Name: STAT PROFILE
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454
• MDR Report Key: 17217519
• MDR Text Key: 318027470
• Report Number: 17217519
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2023

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: Other
• Device Model Number: PRIME PLUS
• Device Catalogue Number: 57821
• Device Lot Number: 22115004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White