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

Model Number 43370

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/24/2019

Event Type  malfunction  

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 Description

Discrepant creatinine results using nova statsensor meter.No adverse event was reported.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
• Type of Device: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8804722
• MDR Text Key: 151909946
• Report Number: 1219029-2019-00034
• 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: K171059
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: 43370
• Device Lot Number: 4918333129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1