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

Catalog Number 43370

Device Problem False Negative Result (1225)

Patient Problem Cancer (3262)

Event Date 04/23/2014

Event Type  Injury  

Event Description

The hospital had a discrepancy with the creatinine values received from the nova statsensor meter and the vitros analyzer in lab.The statsensor got a result of 1.21 mg/dl and the patient was given contrast.The radiology tech later learned that the patient's cr value according to the lab analyzer was 3.4 mg/dl.This result was confirmed on a different tube on the lab analyzer.The radiology tech then repeated the values with the same tube of blood on the statsensor meter and received results of 1.72 and 2.05 mg/dl.The tube collected was a gel lithium heparin tube and was also a short draw.Since the patient was given contrast media the patient was admitted to the hospital.

Manufacturer Narrative

Investigation was performed following nova protocol which tested retained statsensor creatinine tests strips from the lot number the customer was utilizing at the time of the incident (creatinine test strip lot #4913302249).A total of five result levels of nova statsensor linearity solutions and five target range levels of blood samples were tested.Acceptance criteria: the results will be acceptable if all the measurements of the nova statsensor linearity solutions are within their expected range and the test strip lot passes the clinical accuracy performance if 95% of the overall measured results are found to be within the following criteria: results >1.5 mg/dl are found to be within +/-20% of average vitros value and results

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER
• Type of Device: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL; 200 prospect st.; waltham MA 02454
• Manufacturer Contact: paul macdonald ; 200 prospect st.; waltham, MA 02454 ; 7816473700
• MDR Report Key: 3824458
• MDR Text Key: 15820082
• Report Number: 1219029-2014-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 43370
• Device Lot Number: 4913302249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Hospitalization