MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT PROFILE PRIME PLUS ANALYZER SYSTEM; BLOOD GAS ANALYZER

Model Number	PRIME PLUS
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Prime plus reported higher hematocrit results and does not correlate well when compared to the hemoglobin results.
Additional Manufacturer Narrative
Nova biomedical was notified of a potential issue regarding the hemoglobin and hematocrit results obtained from 5 different devices.Additional information was received after the 30 day timeline, since,thailand was still on lockdown due to covid which made communication with the hospital difficult.An on-site service call could not be done due to the shutdown.An additional contributory factor in the delay in communication was due to chinese new year.In the process of attempting to obtain further information it was identified that sample collection technique was found to be at issue.It was noted that the customer is not using the correct anticoagulant for samples as indicated in the ifu.At present, we are unable to ascertain what values were obtained from what specific device.Nova biomedical is attempting to obtain additional information to clarify.A supplemental report shall be submitted upon receipt of additional information.There was no report of patient harm or any intervention required.
Additional Manufacturer Narrative
Udi: (b)(4).Dhr review for stat profile prime plus microsensor cards, lots 21344062 and 21327067, were completed by a quality control manager and no issues were identified.Dhrs indicated that the released product met all specifications and no issue was identified.Due to covid restrictions in thailand, nova was not able to go on-site to investigate the reported issue.The reported problems were reviewed within nova r&d.As an output of this review, nova initiated additional development work to enhance the overall performance of the prime plus sensor cards.Replacement sensor cards were also sent to the customer and no similar issues have since been reported.A review of post market data was performed by nova's pmd manager, and no other similar issues have been received for either lot of sensors cards.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 13656186
• Report Number: 1219029-2022-00011
• Device Sequence Number: 5749762
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K193246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 12/16/2021
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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 Sex: Unknown