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

Model Number 43370

Device Problem Low Readings (2460)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2020

Event Type  malfunction  

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 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
• Type of Device: STATSENSOR
• 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: lee perloff ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 10545787
• MDR Text Key: 207314988
• Report Number: 1219029-2020-00044
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10385480433706
• UDI-Public: 10385480433706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43370
• Device Catalogue Number: 43370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1