MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; CREATININE TEST SYSTEM

Model Number	1.0
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information and further details wil be provided in a supplemental report.
Event or Problem Description
The customer reported discrepant creatinine results on a statsensor meter sn (b)(4)while using strips with lot number 4921209129.The results were questioned and the samples were run on a lab chemistry analyzer which confirmed the discrepant values.The patient was not treated based off of the results from the meter and there were no adverse interactions.There was no patient harm or intervention 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
The customer reported discrepant creatinine results on a statsensor meter sn (b)(6) while using strips with lot number 4921209129.The results were questioned and the samples were run on a lab chemistry analyzer which confirmed the discrepant values.The patient was not treated based off of the results from the meter and there were no adverse interactions.There was no patient harm or intervention reported.Dhr reviews for the statsensor meter and test strips were performed by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter, test strip batch, and control solutions.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.The retained test strips met all performance acceptance criteria for whole blood and linearity testing.The customer's complaint could not be reproduced and no root cause was able to be identified.Nova will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
• Common Device Name: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13117443
• Report Number: 1219029-2021-00052
• Device Sequence Number: 17309544
• Product Code: CGL
• UDI-Device Identifier: 00385480440523
• UDI-Public: 00385480440523
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K171059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2022

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: 1.0
• Device Catalogue Number: 44052
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 01/26/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/28/2022; 02/24/2022
• 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: Male