BD MACRO-VUE¿ RPR CARD TEST

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: CATALOG 275005; LOT NUMBER 2311227. SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY. TEST WAS PERFORMED USING DISPENTIRS AND MICROPIPETTE. NO DISCREPANCY WAS OBSERVED. CONTROL LOT (3009503) CUSTOMER BATCH NUMBER (2311227). ENCLOSED RESULTS USING MICROPIPETTES AND DISPENTIRS SERUM NO. 15: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO. 18: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 AND REACTIVE MINIMAL AT 1:2. SERUM NO. 19: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:2 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 29, 34 AND 38: ALL LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1 SERUM NO'S.3,4, 7: ALL LOTS SHOWED NEGATIVE RESULTS. TWO PHOTO RECEIVED, REACTION ON WELL CAN'T BE DEFINED DUE TO THE REFLECTION OF THE LIGHT AND UNKNOWN TIME REACTION TIME WE WERE UNABLE TO REPRODUCED CUSTOMER INQUIRED. ANTIGEN PERFORMANCE WAS AS EXPECTED. BOTH TEST YIELD IN SAME REACTIVITY DEVICE HISTORY RECORD (DHR) REVIEW WAS SATISFACTORY; NO DEVIATIONS WERE REPORTED. IN-PROCESS AND QC TESTING WERE WITHIN SPECIFICATION.

Description of Event or Problem

REPORT 1 OF 3. IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 INCIDENTS OF RESULTS DISCREPANCY OVER THE LAST FEW MONTHS THERE HAS BEEN SOME INCIDENTS WHEN USING THE DISPOSABLE DISPENSTIRS PATIENTS APPEARED NONREACTIVE, BUT THE PATIENTS HAVE HAD A HISTORY OF BEING REACTIVE. WHEN WE USE THE MLA MICROPIPETTE TO DISPENSE 50 UL THERE IS A SIGNIFICANT INCREASE IN REACTIVITY. ERRONEOUS RESULT WAS REPORTED. A NONREACTIVE RPR WAS REPORTED ON A PATIENT; ONE OF OUR CLIENTS TESTED THAT PATIENT USING THE SAME BD MACRO-VUE RPR KIT AND RECEIVED A REACTIVE RESULT. THERE WAS NO IMPACTED TO THE PATIENT AS OUR CLIENT TREATED THE PATIENT.

Additional Manufacturer Narrative

INITIAL REPORTER EMAIL: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

REPORT 1 OF 3 IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 INCIDENTS OF RESULTS DISCREPANCY OVER THE LAST FEW MONTHS THERE HAS BEEN SOME INCIDENTS WHEN USING THE DISPOSABLE DISPENSTIRS PATIENTS APPEARED NONREACTIVE, BUT THE PATIENTS HAVE HAD A HISTORY OF BEING REACTIVE. WHEN WE USE THE MLA MICROPIPETTE TO DISPENSE 50 UL THERE IS A SIGNIFICANT INCREASE IN REACTIVITY. ERRONEOUS RESULT WAS REPORTED. A NONREACTIVE RPR WAS REPORTED ON A PATIENT; ONE OF OUR CLIENTS TESTED THAT PATIENT USING THE SAME BD MACRO-VUE RPR KIT AND RECEIVED A REACTIVE RESULT. THERE WAS NO IMPACTED TO THE PATIENT AS OUR CLIENT TREATED THE PATIENT.