STAT SENSOR CREAT-TEST STRIPS

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE HAS NOT RETURNED TO NOVA AS OF YET; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS BEING COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem

THE CUSTOMER REPORTS DISCREPANT CREATININE RESULTS. THE PATIENT DID NOT HAVE A PRE-SCAN INTRAVENOUS HYDRATION DONE AND WAS RETESTED. THERE WAS NO PATIENT INJURY, HARM, OR ADDITIONAL TREATMENT PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL AND CORRECTED INFORMATION: B4, D10, G7, H2, H4, H6, H10. THE COMPLAINT SAMPLE FOR THE METER S/N: (B)(6) WAS RETURNED ON (B)(6) 2020, FOR EVALUATION. THE EVALUATION IS CURRENTLY UNDERWAY AND UPON COMPLETION OF THIS INVESTIGATION AND THE TESTING OF THE RETAIN STRIPS, STATSENSOR CREATININE TEST STRIPS, LOT# 4920104129, A FINAL REPORT WILL BE PROVIDED. A DHR REVIEW WAS CONDUCTED FOR THE STATSENSOR CREATININE TEST STRIPS, LOT# 4920104129. DEVICE HISTORY RECORD (DHR) REVIEWS FOR THE STATSENSOR CREATININE TEST STRIPS, LOT# 4920104129 AND STATSENSOR CREATININE METER, S/N (B)(6) WERE PERFORMED BY THE QUALITY ENGINEER ON (B)(6) 2020. THE REVIEW INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING AND RELEASE OF THE METER AND TEST STRIP BATCH. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHR INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS.

Additional Manufacturer Narrative

UDI: (B)(4). AS REPORTED BY THE CUSTOMER, THERE WERE DISCREPANT CREATININE RESULTS. THE COMPLAINT SAMPLE FOR THE METER S/N: 47034716229 WAS RETURNED FOR EVAULATION. THE RETURNED STATSENSOR STRIPS, LOT # 4920104129, WERE MISTAKENLY DISCARDED UPON RECEIPT BY NOVA. HOWEVER, IT WAS DETERMINED THAT TESTING OF RETURNED STRIPS WOULD HAVE BEEN USELESS AS THEY WERE NOT SHIPPED BACK IN A COOLER. STATSENSOR TEST STRIPS ARE REFRIGERATED PRODUCT. TESTING OF RETAINED STATSENSOR CREATININE TEST STRIPS, LOT# 4920104129 AND RETURNED STATSENSOR METER SN 47034716229, MET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND WHOLE BLOOD SAMPLES AND NO DISCREPANT VALUES WERE OBTAINED. THE CONCLUSION OF THIS INVESTIGATION IS THAT THE DISCREPANT CREATININE RESULT ISSUE REPORTED COULD NOT BE REPRODUCED. NO PATIENT IMPACT WAS REPORTED. NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE AND NO FURTHER ACTION IS REQUIRED AT THIS TIME.