STATSTRIP CONN HB/HCT METER SYSTEM
Received Apr 13, 2021 · Event occurred Jan 23, 2021
Report 1219029-2021-00016 · MDR key 11659017
Device
Product problems
- Patient Data Problem
- Patient Data Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
Additional Manufacturer Narrative
THERE WAS NO REPORT OF PATIENT HARM OR ANY INTERVENTION REQUIRED. THERE CURRENTLY IS A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. IN ADDITION, THE PRODUCT ON FILE IS NOT SOLD IN THE UNITED STATES OR ITS TERRITORIES AND DOESN'T HAVE AN ASSIGNED 510K. HOWEVER, NOVA BIOMEDICAL IS THE MANUFACTURER OF STATSTRIP CONN HB/HCT METER SYSTEM.
Description of Event or Problem
THE CUSTOMER REPORTED THAT AFTER USING BARCODE SCANNER FOR INPUTTING PATIENT ID TO THE METER, THE PATIENT ID WAS INCORRECT AND NOT THE ACTUAL PATIENT ID. THE USER FOUND THE ID INCORRECT ON SCREEN OF THE METER BEFORE TESTING. IT WAS REPORTED THE PATIENT DID NOT HAVE AN ADVERSE EFFECT ON THE TESTING OR PATIENT HARM.