MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE PRIME PLUS ANALYZER SYSTEM; WHOLE BLOOD HEMOGLOBIN ASSAYS,

Model Number	57400
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Pulmonary Dysfunction (2019)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to results in question the patient received a blood transfusion.No reported sequela.The prime plus analyzer was evaluated by the service manager on 2022-10-17.The analyser was checked, same reagent onboard.Qcs were fine, no error message found.Other patient values were not affected.
Event or Problem Description
Customer reports discrepancies in hb results for one patient.
Additional Manufacturer Narrative
The customer complaint could not be confirmed or replicated.No products were returned for investigation.The patient had 5 different specimens collected over a period of 16 hours (2 arterial and 3 venous).The data does not indicate when (time) they tested in the laboratory and obtained the 5.1 so this information is of little value to the timeline.The last specimen appears to be after the unit of blood was given and the patient hct and thb increased.Overall, this patient appears to have a unique unknown condition because the patients' hct to thb ratio for all 5 specimens is approximately 5/1 compared to the normal 3:1 ratio.Based upon the data, it appears the thb was artificially low due to an unknown interference or the hct is artificially high for the same reason.The lab data does not provide any insight in this determination.All qc testing of the device were within expected ranges.No other patients were affected, making this an isolated case.A conclusive root cause could not be identified.Nova biomedical will continue to monitor for this or similar events.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Common Device Name: WHOLE BLOOD HEMOGLOBIN ASSAYS,
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454 9141
• Manufacturer Contact: patrick sinclair ; 200 prospect st.; waltham, MA 02545-9141 ; 7818940800
• MDR Report Key: 15799839
• Report Number: 1219029-2022-00046
• Device Sequence Number: 14231379
• Product Code: GKR
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 57400
• Device Catalogue Number: 57400
• Device Lot Number: 22125005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Female