NOVA STATSTRIP HOSPITAL METER SYSTEM
Received Feb 10, 2022 · Event occurred Apr 9, 2022
Report 1219029-2022-00008 · MDR key 13505963
Device
Product problems
- Patient Data Problem
- Patient Data Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THERE IS CURRENTLY A PENDING INVESTIGATION. THE CUSTOMER IS UNSURE OF THE EXACT METER BUT HAS NARROWED IT DOWN TO FOUR POSSIBLE SERIAL NUMBERS. THOSE SERIAL NUMBERS ARE (B)(4). NOVA IS REQUESTING ADDITIONAL INFORMATION AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
THE CUSTOMER REPORTS THAT A STATSTRIP METER SCANNED A PATIENT ARMBAND INCORRECTLY. WHEN ONE PATIENT WAS SCANNED, A DIFFERENT PATIENT'S DATA APPEARED. AFTER A RESCAN, THE CORRECT PATIENT'S INFORMATION APPEARED SO THE RESPONSIBLE METER'S SERIAL NUMBER WAS NOT TAKEN NOTE OF. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER PROVIDED SAMPLES OF THE ARMBANDS THAT ARE USED AT THEIR FACILITY. THE ARMBANDS/BARCODES WERE GRADED AT NOVA BY A VALIDATED SCANNER AND THE BARCODES GRADED POORLY. IT WAS RECOMMENDED TO THE CUSTOMER TO IMPROVE THEIR BARCODE PRINTING. DHR REVIEWS WERE PERFORMED ON THE FOUR METERS THAT THE CUSTOMER SUSPECTED AND THERE WERE NO ABNORMALITIES OBSERVED.