STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT WERE NOT SUCCESSFUL. NOVA BIOMEDICAL WAS UNABLE TO IDENTIFY WHAT THE ALLEGED ISSUE WAS FOR EACH OF METERS IDENTIFIED ON THE MEDSUN REPORT AS THIRTEEN OF THE METER SERIAL NUMBERS WERE REDACTED. A DHR REVIEW WAS PERFORMED ON THE ONE METER SERIAL NUMBER PROVIDED. IT IS NOT KNOWN WHAT THE SPECIFIC ISSUE ASSOCIATED WITH THIS METER. THE DHR REVIEW SHOWED NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THERE WAS NO ALLEGATION OF HARM TO PATIENTS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

MEDSUN REPORT (B)(4). 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 # (B)(4) IMPACTED SERIAL #'S [REDACTED 13 SERIAL NUMBERS] THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE.

Additional Manufacturer Narrative

ON THE INITIAL SUBMISSION THE MDR NUMBER REFERENCE WAS PROVIDED IN SECTION B5. SUBMISSION OF THIS REPORT IS TO CORRECT THE LOCATION AND ADD TO H10.