MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STAT PROFILE PRIME PLUS; GLUCOSE TEST SYSTEM

Model Number	PRIME PLUS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that the nova prime plus analyzer sn (b)(4) returned a lower creatinine result than a reference analyzer.The patient was given contrast based off of this result for a ct scan.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
Additional information: b4, g1, g4, g6, h2, h4, h5, h6, h10 corrected information: d2 udi:(b)(4) the user reported an incident with discpreant patient results when compared to a reference analyzer while measuring creatinine with a statprofile prime plus analyzer, serial number (b)(6).This occurred on (b)(6) 2022.The analyzer did not indicate there was a problem with the sample in anyway before producing the results, and the patient received ct contrast prior to the reference analyzer producing a discrepant result.The analyzer and sensors were not returned to nova biomedical for investigation.The manufacturer retains of the sensor used by the customer were unavailable, but retains of a similar lot which was produced the same day with same materials as the sensor in question were available and tested.The sensor produced acceptable values for quality control tests, and precision tests with whole blood samples were within specification.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be reproduced using manufacturer retains of a similar lot of sensor card used by the customer.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

• Brand Name: NOVA STAT PROFILE PRIME PLUS
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 13587092
• Report Number: 1219029-2022-00010
• Device Sequence Number: 11864628
• Product Code: CGL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K200349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022
• 2 Devices were Involved in the Event: 1 2

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: 01/27/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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 Age: 61 YR
• Patient Sex: Male