NOVA STATSENSOR CREATININE HOSPITAL METER

Additional Manufacturer Narrative

THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS REPORT ONE OF TWO. PLEASE SEE REPORT 1219029-2021-00022 FOR THE SECOND FILING.

Description of Event or Problem

NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING DISCREPANT CREATININE RESULTS USING A STATSENSOR HOSPITAL METER, SERIAL NUMBER (B)(4) AND CREATININE TEST STRIPS LOT 4920177139. IT WAS REPORTED THE PATIENT DISAGREED WITH THE INITIAL RESULTS. TESTING WITH ANOTHER METER SHOWED SIMILAR RESULTS. WHEN SAMPLES WERE RUN ON A LAB ANALYZER, THE RESULTS DID NOT MATCH EITHER OF THE METERS. NO INAPPROPRIATE TREATMENT WAS STARTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULT. THIS IS REPORT ONE OF TWO.

Additional Manufacturer Narrative

PLEASE NOTE, THE PREVIOUS REPORT WAS DATED FOR JUNE 14TH, 2021 (06/14/2021). THIS IS AN ERROR. THE CORRECT DATE OF THE REPORT IS JUNE 15TH, 2021 (06/15/2021). REPORT 2 OF 2.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED AND IS STILL PENDING. FURTHER DETAILS WILL BE PROVIDED IN AN ADDITIONAL SUPPLEMENTAL REPORT WHEN THEY BECOME AVAILABLE.

Additional Manufacturer Narrative

UDI: (B)(4). THE CUSTOMER REPORTED AN INCORRECT PATIENT RESULT FOR CREATININE WAS RECEIVED WHEN RUNNING A PATIENT SAMPLE ON A STATSENSOR METER (B)(6). THIS OCCURRED ON (B)(6) 2021. THE METER DID NOT INDICATE THERE WAS A PROBLEM WITH THE SAMPLE IN ANYWAY BEFORE PRODUCING THE RESULT. THE CUSTOMER INDICATED THERE WAS NO ADVERSE TREATMENT OF THE PATIENT DUE TO THE INCIDENT. THE METER WAS RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE METER WAS TESTED WITH MANUFACTURER RETAINS OF THE STRIPS WITH LOT 4920177129. ALL TESTS PASSED THE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES WHEN COMPARED TO FIVE ADDITIONAL METERS. NO DISCREPANCIES WERE OBSERVED BETWEEN BLOOD RESULTS OBTAINED BY THE RETAINED TEST STRIPS AND THE REFERENCE METHOD, SIEMENS EXL ANALYZER, WHEN USED ON THE RETURNED METER. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE METER AND THE STRIP LOT BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE METER AND TEST STRIP BATCH. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AFTER TESTING THE RETURNED METER AND THE MANUFACTURER RETAINS OF THE STRIPS. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, AND NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS. REPORT 2 OF 2.