STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Nov 13, 2019 · Event occurred Oct 3, 2019
Report 1219029-2019-00062 · MDR key 9315005
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical CorpModel number
42214Lot number
0318309249
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A USER FACILITY REPORTED DISCREPANT GLUCOSE RESULTS FOR A NEONATE PATIENT. THERE WAS NO PATIENT HARM REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NOVA BIOMEDICAL HAD PREVIOUSLY OBSERVED AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO HEELSTICK TECHNIQUE WHEN TESTING BLOOD GLUCOSE IN NEONATES. AS A RESULT OF THIS, COMPREHENSIVE TESTING WAS PERFORMED ON MULTIPLE STRIP LOTS SIMULATING NEONATE PATIENT USAGE, AND DETERMINED THAT WITH PROPER SAMPLE COLLECTION AND HANDLING THE SYSTEM GIVES ACCURATE RESULTS. A PREVENTATIVE ACTION HAD BEEN PREVIOUSLY INITIATED TO REVISE THE LABELLING TO ADD A PRECAUTION IN REGARDS TO CAPILLARY HEELSTICK SAMPLE COLLECTION.