MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE® PRIME PLUS ANALYZER SYSTEM; WHOLE BLOOD HEMOGLOBIN ASSAYS

Model Number	PRIME PLUS
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding analysis of sodium, potassium, chloride, and blood urea nitrogen (bun) results during the treatment of a patient on a statprofile prime plus analyzer with serial number (b)(4).The results were reported but the clinician questioned the accuracy of these when compared to the clinical presentation of the patient.An additional sample from the patient was run using the reference analyzer beckman au which confirmed the initial results were inaccurate.No patient harm or adverse treatment due to the inaccurate results was reported.
Additional Manufacturer Narrative
Additional information: udi: (b)(4).Device history record reviews were completed for prime plus sn: (b)(6), microsensor card pn: 61615, lot: 22063005, calibrator pack pn: 57831, lot: 22047040, qc pack pn: 57841, lot: 21200036 and reference sensor pn: 57823, lot: 22061045.The dhrs confirmed that all products met all specifications when released to finished goods.A 2 year look back in the data base did not return any result for lot/sn in question.Per the investigation report, the discrepancies in patient sample are believed to have resulted from reference flow issue which can be caused by debris entering the flow path or the calibrator pack that was replaced around the same time as the sensor in this case.It is difficult to confirm these findings as consumables were not returned.Therefore, no further actions are required at this time.Nova will continue monitoring for recurrence.

• Brand Name: STAT PROFILE® PRIME PLUS ANALYZER SYSTEM
• Common Device Name: WHOLE BLOOD HEMOGLOBIN ASSAYS
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• 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: 14944290
• Report Number: 1219029-2022-00042
• Device Sequence Number: 6196097
• Product Code: CDS
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/29/2022

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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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: 76 YR
• Patient Sex: Male