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

Model Number 44052

Device Problems Application Program Problem: Dose Calculation Error (1189); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

According to the radiology manager and lab director in a follow up call with (b)(6) medical center; it is still unknown if there was an adverse effect from the contrast being administered.According to them,".There was nothing remarkable about the patient or the test; the patient bled well and there weren't any errors generated." they are going to continue to monitor patient results and make sure they are correlating with the lab.

Event Description

The statsensor meter reported a result of 1.97mg/dl (egfr 37) and the lab reported a result of 3.60mg/dl (egfr 17).The hospital's policy says to give contrast dye when the egfr is greater than 30, so they did.They only later found out that the egfr was 17 and realized they shouldn't have administered contrast dye.It is unknown if the patient was adversely affected by this.

Manufacturer Narrative

Section was updated to reflect the correct product identification.Complaint was not confirmed.Meter and test strips were not returned.Dhr reviews were conducted on both the meter and strips.The dhr was complete and contained all relevant data indicating the released product met all specifications.Retained testing of the lot revealed no performance anomalies.The performance of nova statsensor creatinine test strip lot# 4916348129 passes all acceptance criteria for linearity solutions and blood samples.Results for linearity solutions are within the linearity solution ranges.No discrepancies were observed between the blood results obtained by retained nova stat sensor creatinine test strips.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER
• Type of Device: CLINICAL CHEMISTRY CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 165 lexington road; billerica MA 01821
• Manufacturer Contact: rachel kula ; 200 prospect st; waltham, MA 02454-9141 ; 7818940800
• MDR Report Key: 6886476
• MDR Text Key: 89532443
• Report Number: 1219029-2017-00008
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2017
• Device Model Number: 44052
• Device Lot Number: 4916348129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2015
• 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