STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Feb 3, 2021 · Event occurred Dec 20, 2020
Report 0001219029-2021-00001 · MDR key 11273300
Device
Product problems
- Patient Data Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THE STATSTRIP WIRELESS METER SERIAL NUMBER (B)(4). THE METER ALONG WITH THE PATIENT'S WRISTBAND WERE RETURNED TO NOVA ON (B)(6) 2021. AN INVESTIGATION IS CURRENTLY UNDERWAY BASED ON THE INFORMATION AND MATERIAL PROVIDED AND A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
CUSTOMER REPORTED TO NOVA BIOMEDICAL ON (B)(6) 2021 THAT A BAR CODE SCAN MIS-READ OCCURRED ON A STATSTRIP WIRELESS METER SERIAL NUMBER (B)(4) WHILE SCANNING A PATIENT WRISTBAND'S INFORMATION. ON (B)(6) 2020 THE REPORTED MIS-READ WAS DISCOVERED WHEN THE CUSTOMER TRIED TO FIND A GLUCOSE RESULT IN THEIR HIS/LIS NETWORK BUT COULD NOT FIND IT. THEY REVIEWED THE METER AND FOUND THAT THE BAR CODE IN MEMORY DID NOT MATCH THE BAR CODE THAT WAS SCANNED. NO PATIENT IMPACT OR ADVERSE EVENT REPORTED.