DADE INNOVIN

Description of Event or Problem

THE CUSTOMER REPORTED THAT A FALSELY ELEVATED PT (PROTHROMBIN TIME) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A CA-660 SYSTEM INSTRUMENT MEASURED WITH INNOVIN REAGENT (LOT REQUESTED). THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CRITICAL VALUE. HOWEVER, BOTH THE TECHNICIAN AND THE PHYSICIAN QUESTIONED THE RESULT, AND A REDRAW WAS REQUESTED. THE SAMPLE WAS REPEATED ON THE SAME CA-660 SYSTEM (AFTER REDRAW AND REPEAT TESTING OF THE ORIGINAL SAMPLE). THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT AND WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, PT RESULT.

Additional Manufacturer Narrative

AN UNITED STATES (US) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT A DISCORDANT PT RESULT THAT WAS OBTAINED ON ONE PATIENT SAMPLE ON A CA-660 INSTRUMENT. SIEMENS HEALTHINEERS REVIEWED AND INVESTIGATED THE INFORMATION PROVIDED. THIS OBSERVATION IS AN ISOLATED, NON-REPRODUCIBLE EVENT WITH NO INDICATION OF SYSTEM OR REAGENT MALFUNCTION. THE ERROR PATTERNS ("NO COAG MEASUREMENT", "ANALYSIS TIME OVER", NO ENDPOINT) INDICATE A TEMPORARY, SAMPLE-SPECIFIC INTERFERENCE WITH CLOT DETECTION. NORMAL RESULTS ON REDRAW AND REPEAT TESTING ARGUE AGAINST A PERSISTENT ANALYTICAL ISSUE. THIS INDICATES THE ISSUE IS A PRE-ANALYTICAL ISSUE WITH THE SAMPLE. SYSTEM WORKS AS SPECIFIED. CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE USED REAGENT. THEREFORE, SECTION D4 (LOT NUMBER, EXPIRATION DATE AND PRIMARY UDI NUMBER) AS WELL AS H4 (MANUFACTURE DATE) REMAIN EMPTY.