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

Model Number PRIME PLUS

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

Nova biomedical (nova) was made aware of a potential issue regarding analysis of bicarbonate (hco3) and base excess of blood (be-b) 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 epoc analyzer which confirmed the initial results were inaccurate.No patient harm or adverse treatment due to the inaccurate results was reported.

Manufacturer Narrative

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
• Type of Device: 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: 14944310
• MDR Text Key: 304210860
• Report Number: 1219029-2022-00043
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRIME PLUS
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female