inforMED
MalfunctionPZI

STATSTRIP

Received Jan 14, 2025 · Event occurred Dec 2, 2024

Report 21147776 · MDR key 21147776

Device

Generic name

Prescription Use Blood Glucose Meter For Near-patient Testing

Model number

63685

Catalog number

63685

Patient

2 MO · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON [REDACTED DATE] OUR HOSPITAL SYSTEM WENT LIVE WITH NOVA BIOMEDICAL GLUCOMETERS. WE PURCHASED 112 METERS AND DISBURSED THEM THROUGHOUT THE MEDICAL CENTER AFTER EDUCATION AND GO LIVE SUPPORT. ALL UNITS WERE DEPLOYED WITH GLUCOMETERS AND SUPPLIES. AFTER GO-LIVE, MULTIPLE ISSUES AROSE WITH THE GLUCOMETERS SUCH AS: OVERHEATING, CONNECTIVITY ISSUES, STRIP RECOGNITION ERROR, FROZEN SCREEN, AND RESULTS NOT CROSSING OVER TO EMR. ALL CONCERNS ESCALATED TO POINT OF CARE COORDINATOR AND LAB LEADERSHIP. OUR LEADERSHIP TEAM ESCALATED CONCERNS TO VENDOR TO INVESTIGATE THE ISSUE AND RESOLVE. FIELD SERVICE REPS WERE ON SITE AND DOWNLOADED A NEW SOFTWARE VERSION, WHICH HELPED WITH SOME ISSUES BUT NOT ALL. MANUFACTURER- NOVA BIOMEDICAL, MODEL: STATSTRIP (GENERATION 2.0 DEVICE), REFERENCE # 63685, IMPACTED SERIAL #'S, [REDACTED 13 SERIAL NUMBERS].