MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Model Number	43370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing.Evaluation of retain strips and dhr reviews for both the meter and test strip batch to be completed.Qc results before and after the reported incident were in range, meter was not returned for investigation.The healthcare professional reported that the patient was a difficult stick and the fingerstick was attempted twice.
Event or Problem Description
Discrepant creatinine results using nova statsensor meter.No adverse event was reported.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
• Common Device Name: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• MDR Report Key: 8804722
• Report Number: 1219029-2019-00034
• Device Sequence Number: 2693705
• Product Code: CGL
• UDI-Device Identifier: 10385480433706
• UDI-Public: 10385480433706
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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 Expiration Date: 11/29/2019
• Device Model Number: 43370
• Device Lot Number: 4918333129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1