MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSENSOR; STATSENSOR CREATININE ELECTRODE

Model Number 44052

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Results received from lab at 16:15 which indicated the patient should not have received contrast dye for the ct scan.Creatinine test strip lot passed qc testing.Patient had hematocrit of 27.5% which is contraindicated per label copy (hct range 30-60%).Creatinine interferences: "the creatinine meter exhibits no interferences in blood specimens with hematocrits from 30% to 60% or with varying oxygen content.".

Event Description

Facility stated they received a false creatinine value on the stat sensor meter.

Manufacturer Narrative

The customer complaint could not be confirmed.The alleged deficiency of discrepant results could not be reproduced.The performance of nova stat sensor creatinine test strip lot #4916098249 passes all acceptance criteria for linearity solutions and blood samples.Results for linearity solutions are within linearity solution ranges and there were no discrepancies observed between the results by retained nova stat sensor creatinine test strip lot 4916098249 and the rxl chemistry analyzer.There were no discrepancies observed between the results of the twenty five(25) returned nova stat sensor creatinine test strip lot #4916098249 and the rxl chemistry analyzer.

• Brand Name: STATSENSOR
• Type of Device: STATSENSOR CREATININE ELECTRODE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer Contact: paul macdonald ; 200 prospect st; waltham, MA 02454-9141 ; 7818940800
• MDR Report Key: 6079198
• MDR Text Key: 59562828
• Report Number: 1219029-2016-00003
• Device Sequence Number: 1
• Product Code: CGL
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 44052
• Device Lot Number: 4916098249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR