INNOVANCE PFA-200 SYSTEM

Description of Event or Problem

DISCORDANT, FALSELY LOW INNOVANCE P2Y (P2Y) RESULTS WERE OBTAINED ON 19 DIFFERENT PATIENT SAMPLES ON 14 DIFFERENT DAYS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED SINCE THE PATIENTS WERE ALL TAKING THE MEDICATION CLOPIDOGREL. NO REPEAT TESTING WAS PERFORMED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW P2Y RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). AS PER THE INNOVANCE P2Y INSTRUCTIONS FOR USE (IFU): "IN CASE THE INNOVANCE® PFA P2Y CLOSURE TIME OBTAINED WITH THE INITIAL TEST IS BELOW OR EQUAL TO THE ANALYTICAL CUT-OFF, PLEASE REPEAT THE TEST WITH THE SAME BLOOD SAMPLE AGAIN IN POSITION A OF THE PFA SYSTEM". THE CUSTOMER INDICATED THAT THEY DID NOT REPEAT THE SAMPLES THAT RECOVERED BELOW THE CUT-OFF. IT CANNOT BE RULED OUT THAT THE PATIENTS DID NOT TAKE THE MEDICATION AS REQUESTED. IT IS ALSO KNOWN THAT A CERTAIN PERCENTAGE OF PATIENTS ARE RESISTANT TO ACETYLSALICYLIC ACID (ASA) AND CLOPIDOGREL. ADDITIONALLY, SAMPLE QUALITY ISSUES SUCH AS INADEQUATE MIXING OR OTHER MISHANDLING OF THE SAMPLES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE INNOVANCE PFA-200 SYSTEM IS NOT MARKETED IN THE UNITED STATES (US). THIS MDR IS FILED FOR THE US SIMILAR SYSTEM (PFA-100 SYSTEM). THE PFA-100 SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10444868, UNIQUE DEVICE IDENTIFIER (B)(4) AND PMA/510(K) K060489. MDRS 9610806-2022-00024, 9610806-2022-00025, 9610806-2022-00027, 9610806-2022-00028, 9610806-2022-00029, 9610806-2022-00030, 9610806-2022-00031, 9610806-2022-00032, 9610806-2022-00033, 9610806-2022-00034, 9610806-2022-00035, 9610806-2022-00036, AND 9610806-2022-00037. WERE FILED FOR THE DISCORDANT RESULTS OBTAINED ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022, RESPECTIVELY.