MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE PRIME CCS ANALYZER SYSTEM; BLOOD GASES (PCO2, PO2), AND BLOOD PH TEST SYSTEM

Model Number	PRIME CCS COMP
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the uncalibration of the pco2 parameter while using a statprofile prime ccs comp analyzer with the sensor card lot 21123005.It was reported the uncalibration caused a delay in reporting the patient's results.No patient harm was reported.
Additional Manufacturer Narrative
Udi: (b)(4).The distributor reported a customer was using a prime ccs comp analyzer with sensor card lot 21123005 when the pco2 parameter became uncalibrated and would not pass quality control measures.The calibration failure prevented the users from running patient samples which caused a delay in patient treatment.No patient harm was reported due to the analyzer system.The sensor card reported by the distributor was unavailable to be returned for evaluation.The investigation utilized retained sensor cards of a lot produced on the same day as there were no retains available from the same lot the customer had reported, testing the slope values over a time period.Throughout the investigation timeframe, the pco2 parameter produced slope values within their respective expected ranges.The investigation was unable to reproduce the error reported by the customer.Device history record (dhr) reviews were performed for the meter by a quality control engineer.The review included an assessment of the production, testing, and release of the meter.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 sensor cards of the same lot used by the customer.The root cause was unable to be identified, and nova biomedical will continue to monitor for recurrence of similar events.

• Brand Name: STAT PROFILE PRIME CCS ANALYZER SYSTEM
• Common Device Name: BLOOD GASES (PCO2, PO2), AND BLOOD PH TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• MDR Report Key: 12568618
• Report Number: 1219029-2021-00033
• Device Sequence Number: 11768259
• Product Code: CHL
• UDI-Device Identifier: 00385480420334
• UDI-Public: 00385480420334
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: No Information
• Device Expiration Date: 04/21/2022
• Device Model Number: PRIME CCS COMP
• Device Catalogue Number: 42033
• Device Lot Number: 21123005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1