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

Model Number	53657
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the device is still in use and is not available for return.An investigation is currently underway based on the information provided and a device history record (dhr) review has been requested as well as testing of the sensor card retains.A supplemental report will be submitted upon completion.
Event or Problem Description
Customer reported on (b)(6) 2020 that pco2 patient results obtained on a nova prime ccs comp w/scanner analyzer sn (b)(4) were high compared to their lab analyzer.
Additional Manufacturer Narrative
Additional and corrected information: b4, g6, h1, h2, h6, h10.The database from the suspect analyzer was received from the nova distributor on 28sep2020 for evaluation.A device history record (dhr) review has been requested and the evaluation of the database is currently underway.Upon completion of this investigation a final report will be provided.
Additional Manufacturer Narrative
Corrected and additional information: b4, g6, h1, h2, h3, h4, h6, h10.Udi: (b)(4).As reported by the customer, the patient had discrepant high pco2 results.An investigation was completed and concluded that the retained sensor cartridges from lot 20119024 met performance criteria and that the complaint could not be reproduced.A review of the customer database for prime ccs comp analyzer, sn: (b)(6), determined that the qc and slope values were within established ranges.Three drift errors were observed the day before the high pco2 result, this does not indicate issue with either the analyzer or the card.A device history record (dhr) reviews for the analyzer and reported sensor card lots were performed by the investigator.The reviews included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.An evaluation of the customer database did not reveal any issue with either the analyzer or the card.A capa is not required as a result of this investigation because the issue could not be reproduced.The root cause for this is undetermined.The cause(s) of the difficulty reported by the customer could not be determined.Trends will be monitored for this or similar complaints.
Additional Manufacturer Narrative
Additional and corrected information: b4, g6, h1, h2, h6, h10.The database from the suspect analyzer was received from the nova distributor on 28sep2020 for evaluation.A device history record (dhr) review has been requested and the evaluation of the database is currently underway.Retained sensor cartridges lot number 20119024 are being tested with patient whole blood samples over a time period of 13 days.Upon completion of this investigation a final report will be provided.

• Brand Name: STAT PROFILE PRIME CCS ANALYZER SYSTEM
• Common Device Name: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 10601007
• Report Number: 1219029-2020-00046
• Device Sequence Number: 16464141
• Product Code: CHL
• UDI-Device Identifier: 00385480536578
• UDI-Public: 00385480536578
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K141907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 53657
• Device Catalogue Number: 53657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 09/08/2020; 09/08/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/28/2020; 11/23/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1