Description of Event or Problem · 1
THE USER RECEIVED QUESTIONABLE RESULTS FOR INTACT HUMAN CHORIONIC GONADOTROPIN PLUS SS-SUBUNIT (HCG+SS) ON THE ADDITIONAL E MODULE (E2). THE EVENT INVOLVED 25 PATIENT SAMPLES. TWENTY TWO PATIENT SAMPLES GAVE DISCREPANT RESULTS. THE CUSTOMER USES THE (HCG+SS) APPLICATION TO GENERATE A QUANTITATIVE (HCG+SS) RESULT, WHICH IS INTERPRETED AS POSITIVE, NEGATIVE OR BORDERLINE BY THE CUSTOMERS LABORATORY INFORMATION SYSTEM (LIS) WHEN (HCG+SS) IS ORDERED FOR PREGNANCY DETERMINATION. THE CUSTOMER DID NOT PROVIDE THE INTERPRETIVE RESULTS FOR PATIENT SAMPLES 1 THROUGH 14, 21 & 22. THE PATIENT SAMPLES WERE REPEATED ON ANOTHER E MODULE (E1) SERIAL NUMBER (B)(4). PATIENT SAMPLE 1, THE ORIGINAL RESULT WAS 39.6 MIU/ML; THE REPEAT RESULT WAS 1.9 MIU/ML. PATIENT SAMPLE 2, THE ORIGINAL RESULT WAS 16.9 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 3, THE ORIGINAL RESULT WAS 59.3 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 4, THE ORIGINAL RESULT WAS 96 MIU/ML; THE REPEAT RESULT WAS 5.6 MIU/ML. PATIENT SAMPLE 5, THE ORIGINAL RESULT WAS 9.2 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 6, THE ORIGINAL RESULT WAS 45 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 7, THE ORIGINAL RESULT WAS 126 MIU/ML; THE REPEAT RESULT WAS 0.4 MIU/ML. PATIENT SAMPLE 8, THE ORIGINAL RESULT WAS 269 MIU/ML; THE REPEAT RESULT WAS 28 MIU/ML. PATIENT SAMPLE 9, THE ORIGINAL RESULT WAS 15.1 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 10, THE ORIGINAL RESULT WAS 59.8 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 11, THE ORIGINAL RESULT WAS 13.6 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 12, THE ORIGINAL RESULT WAS 73.7 MIU/ML; THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 13, THE ORIGINAL RESULT WAS 20 MIU/ML; THE REPEAT RESULT WAS 0.3 MIU/ML. PATIENT SAMPLE 14, THE ORIGINAL RESULT WAS 609.9 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED WHICH YIELDED A HCG RESULT OF 40.24 MIU/ML. PATIENT SAMPLE 15, THE ORIGINAL RESULT WAS 3.67 MIU/ML. THE USER REPORTED THIS RESULT AS NEGATIVE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 16, THE ORIGINAL RESULT WAS 20.31 MIU/ML. THE USER REPORTED THIS RESULT AS POSITIVE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.3 MIU/ML. PATIENT SAMPLE 17, THE ORIGINAL RESULT WAS 3.14 MIU/ML. THE USER REPORTED THIS RESULT AS NEGATIVE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 18, THE ORIGINAL RESULT WAS 15.1 MIU/ML. THE USER REPORTED THIS RESULT AS BORDERLINE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 19, THE ORIGINAL RESULT WAS 59.81 MIU/ML. THE USER REPORTED THIS RESULT AS POSITIVE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 20, THE ORIGINAL RESULT WAS 13.61 MIU/ML. THE USER REPORTED THIS RESULT AS BORDERLINE OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 0.1 MIU/ML. PATIENT SAMPLE 21, THE ORIGINAL RESULT WAS 221.5 MIU/ML. THE REPEAT RESULT WAS 38.95 MIU/ML. PATIENT SAMPLE 22, THE ORIGINAL RESULT WAS 116.4 MIU/ML. THE REPEAT RESULT WAS 53.8 MIU/ML. THE ORIGINAL RESULTS FOR THESE PATIENT SAMPLES WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS WERE LATER CORRECTED BASED UPON THE RERUN RESULTS. THE PATIENTS WERE NOT AFFECTED BY THIS EVENT. THE REAGENT LOT NUMBER FOR (HCG+SS) WAS 15739702. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS WORN SYRINGE SEALS. HE COMPLETED PREVENTATIVE MAINTENANCE AND RAN PERFORMANCE TESTS WHICH WERE ACCEPTABLE.