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

Model Number	PRIME PLUS
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer indicated that their prime plus analyzer serial number pp1120040c reported patient results for sodium and potassium with a significant difference to laboratory values from same sampling time.Customer confirmed that the patient results were not used for medical decisions and there was no patient injury, harm or additional treatment reported.
Additional Manufacturer Narrative
Udi: (b)(4) the customer reported patient results for na and k with a significant difference to laboratory values from same sampling time.The samples were run on prime plus analyzer with blood gas sensor card lot 21281009, calibrator pack lot 21252047 and qc pack lot 21047090.The event was first observed on (b)(6), 2021.As per customer, there was no patient harm or medical intervention.Device history record (dhr) reviews for the prime plus sensor card lot 21281009, prime plus aqc lot 21047090, prime plus calibrator lot 21252047, prime plus analyzer sn (b)(6) and prime plus reference cartridge lot 21203017 were performed by the quality control manager.The review included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.The customer database was reviewed.It was determined that the reference sensor had been installed on the analyzer almost 2 months.During that time the slopes for na and k were drifty but not out of range.As soon as the reference was replaced slope values became more stable.Testing of retained reference cartridge was not possible as it was not returned from the field and retain is not available.As part of initial troubleshooting, new reference sensor was installed and results returned to expected ranges.No other actions were identified.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect sfreet; 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: 13289443
• Report Number: 1219029-2022-00004
• Device Sequence Number: 19935706
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: PRIME PLUS
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown