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

Model Number	PRIME PLUS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
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 situation where an inaccurate result for sodium (na) was received while using a statprofile prime plus analyzer, (b)(4).The nurse questioned the results as they did not fit the patient's clinical presentation.Additional samples were run across other analyzers and confirmed the initial results were incorrect.No patient harm or adverse treatment due to the inaccurate results was reported.
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
Udi: (b)(4).The customer reported an incorrect patient result for sodium was received when running a patient sample on a statprofile prime plus analyzer sn (b)(6).This occurred on (b)(6) 2021.The analyzer did not indicate there was a problem with the sample in anyway before producing the result but the patient's history was not indicative of the results.There was no harm or adverse treatment due to the inaccurate results.The analyzer and sensors were not returned to nova biomedical for investigation.The manufacturer retains of sensor lot 21125028 were tested.All tests passed the acceptance criteria for linearity solutions and blood samples when ran for five sets analyzing six replicates with each set.No discrepancies were observed between blood results obtained by the retained sensor card when compared to the reference statprofile phox ultra analyzer.Device history record (dhr) reviews were performed for the analyzer and all consumables being used 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 consumable items.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 confirmed after testing the manufacturer retains of the sensor card.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

• Brand Name: STAT PROFILE® PRIME PLUS ANALYZER SYSTEM
• Common Device Name: SODIUM TEST SYSTEM
• 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: 12759051
• Report Number: 1219029-2021-00045
• Device Sequence Number: 4595743
• Product Code: JGS
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K200403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 12/16/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/03/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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