MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT SENSOR CREAT - TEST STRIPS; STATSENSOR

Model Number	43370
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint sample was not returned to nova and no serial or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The product catalog number was provided by nova's clinician for fda reporting purposes.Several attempts were made via phone and email; however, there has been no response.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.No corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.
Event or Problem Description
On (b)(6) 2020 a customer reported that some of their stat sensors were reading lower than their lab analyzers.In one instance a patient was treated based on a statsensor result that read much higher than the lab analyzer.The patient was given contrast for imaging based on the discrepant results.Quality controls for each meter were performed before and after the incident with passing results.There is no further indication of additional treatment to the patient.The initial reporter stated there was no harm to the patient resulting from the contrast provided to the patient.

• Brand Name: STAT SENSOR CREAT - TEST STRIPS
• Common Device Name: STATSENSOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 10545787
• Report Number: 1219029-2020-00044
• Device Sequence Number: 2992476
• Product Code: CGL
• UDI-Device Identifier: 10385480433706
• UDI-Public: 10385480433706
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070068
• 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 faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 43370
• Device Catalogue Number: 43370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1