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

Model Number 57400

Device Problem Erratic Results (4059)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

There was no report of patient harm or any intervention required.There currently is a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

The customer indicated that their prime plus analyzer serial number: (b)(4) reported discrepant pco2 measurement, hco3 and cl are both high.

Manufacturer Narrative

An investigation has been initiated and is currently pending.Further details will be provided in an additional report when they become available.

Manufacturer Narrative

An investigation has been initiated and is currently pending.Further details will be provided in an additional report when they become available.

Manufacturer Narrative

Udi: (b)(4).The customer reported discrepant pco2 as well as hco3 and cl reading high.The samples were run on a prime plus analyzer, serial number (b)(6) with blood gas sensor lot 21167011, calibrator pack lot 21160024, qc pack lot 20175013, reference sensor lot 20157001.The event was first observed on (b)(6) 2021.The same patient sample was run epoc bgem.As per customer, there was no patient harm or medical intervention.The sensor cards were not returned for evaluation, however, the database from both prime plus analyzers sn (b)(6) were reviewed and were as expected for maintaining properly functioning machines.A retained sensor card from lot 21173005 of pn: 61615 was pulled and read on a reader.All the programmed values matched the checksum file.This review showed that the checksum file was as expected and the values were programmed onto the card correctly.A verification of the checksum was not performed on lot 21167011 since the checksum was the same for both lots.Device history records (dhr) reviews for primeplus analyzers (b)(6), auto qc cartridge with creat lot: 20175013, reference cartridge with lot 20157001, calibrator cartridge with creat lot 2116024 and sensor card without hbf, tbil lot 21167011 and 21173005 were performed by the senior quality engineer.The review included an assessment of the production, testing and release of the analyzer and listed consumables.No abnormalities were observed.The dhr confirms that the released products met all specifications.Based on the analysis of the test results for each patient on each analyzer and each date, it was concluded that the two prime plus analyzers performed similarly on all parameters.The reference method used by the customer, epoc bgem, recovered lower.The reason for the difference between two systems is unknown.It is possible that the difference was due to interference resulted by patient's physiological condition or medication on the reference or prime plus system.The retained sensor card was verified, and customer database was also reviewed and no abnormalities were found.Nova will continue to monitor, no further action is required at this time.

• Brand Name: STAT PROFILE PLRIME PLUS ANALYZER SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 12362110
• MDR Text Key: 267957275
• Report Number: 1219029-2021-00031
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (y/n): N
• PMA/PMN Number: K193246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57400
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1