MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM; BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER

Model Number 42014

Device Problem Erratic Results (4059)

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

Event Date 08/31/2021

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 phox ultra abg analyzer serial number: (b)(4) reported discrepant creatinine measurement.There was patient injury, harm or additional treatment reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Udi: (b)(4).The customer reported discrepant creatinine measurement.The samples were run on a phox ultra abg analyzer, serial number (b)(6) with calibrator pack lot 21147030/ part number 48836, qc pack lot 20174053/ part number 48928, creatinine sensor lot 20325009, creatinine membrane lot 21144010.The event was first observed on august 31, 2021.The same patient was run on their chemistry refeerence analyzer.As per the customer, there was no patient harm or medical intervention.The consumables were not returned for evaluation, however, testing of retained membranes, lot 21144010, met the acceptance criteria for performance check and qc level 5.The results were also compared to reference analyzer and found to be within acceptance criteria.The bias observed by the customer could not be reproduced.Device history records (dhr) reviews for the phox ultra abg analyzer, sn (b)(6), phox ultra calibrator, lot 21147030, phox ultra chemistry auto qc, lot 20174053, phox ultra creatinine sensor, lot 20325009, and phox ultra creatinine membrane, lot 21144010, were performed by the quality control manager.The review included an assessment of the production, testing, and release of the analyzer, reagents and consumables.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.Based on information provided by the customer, it is unclear if customer performed daily performance checks.It is possible that the performance check solution was not analyzed on daily basis that resulted in erroneous creatinine results.Customer reported satisfactory result and no other actions were identified.Nova will continue to monitor, no further action is required at this time.

Event Description

The customer indicated that their phox ultra abg analyzer serial number: (b)(6) reported discrepant creatinine measurement.There was no patient injury, harm or additional treatment reported.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Type of Device: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 12549588
• MDR Text Key: 274495140
• Report Number: 1219029-2021-00038
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42014
• Device Catalogue Number: 42014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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