BD MACRO-VUE¿ RPR CARD TEST

Additional Manufacturer Narrative

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

IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST LARGE PARTICLES HAVE BEEN AFFECTING INTERPRETATION OF RESULTS. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PARTICLES ARE TOO LARGE, WHICH AFFECTS THE INTERPRETATION.

Description of Event or Problem

IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST LARGE PARTICLES HAVE BEEN AFFECTING INTERPRETATION OF RESULTS. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PARTICLES ARE TOO LARGE, WHICH AFFECTS THE INTERPRETATION.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: MATERIAL 275005, BATCH 2094445. SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY. SELF SAMPLE RESULTS: CONTROL LOT (2153970) CUSTOMER BATCH NUMBER (2094445). SERUM NO. 13: CONTROL AND RETENTION , SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO'S; 18: CONTROL AND RETENTION SAMPLE, SHOWED REACTIVE RESULTS AT 1:1 AND REACTIVE MINIMAL AT 1:2. SERUM NO¿S. 19: CONTROL AND RETENTION SAMPLE, SHOWED REACTIVE RESULTS AT 1:1- 1:2 AND REACTIVE MINIMAL AT 1:4. SERUM NO¿S. 26, 30 - 38: CONTROL AND RETENTION SAMPLE SHOWED REACTIVE MINIMAL AT 1:1. SERUM NO'S.7, 8 AND 9: ALL LOTS SHOWED NEGATIVE RESULTS. VISUAL INSPECTION WAS PERFORMED TO RETENTION SAMPLES AND NO DISCREPANCY WERE FOUND, NO AGGLUTINATION OR PARTICLE TOO COURSE WERE OBSERVED. NORMAL SIZE OF THE PARTICLE WERE OBSERVED. BATCH RECORD REVIEW DO NOT SHOW ANY DISCREPANCY, ALL TESTING WERE WITHIN SPECIFICATIONS FOR PRODUCT RELEASE. PHOTO RECEIVED FROM CUSTOMER DO NOT SHOW AGGLUTINATION OR COURSE PARTICLE. COMPLAINT UNCONFIRMED BASED OF RETENTION TEST RESULTS, BATCH HISTORY RECORD AND PHOTO EVALUATION. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. SPECIAL ATTENTION SHOULD BE PROVIDED TO: ANTIGEN STORAGE AND USE. SAMPLE AND ROOM TEMPERATURE DURING THE TEST. TYPE OF SPECIMEN USED: COLLECTION AND PREPARATION. ACCORDING OF THE ¿MANUAL OF TEST FOR SYPHILIS¿ EDITION 9.0 THE FOLLOWING ¿SOURCES OF ERROR¿ HAD BEEN IDENTIFIED FOR INCREASE OF REACTIVITY OR FALSE REACTIVITY FOR THE RPR TEST. IF THE TIME OF ROTATION IS TOO LONG, TEST REACTIVITY MAY BE INCREASED. IF THE CARD IS EXCESSIVELY ROTATED AND TILTED (TO AND FRO MOTIONS) BY HAND AFTER REMOVAL FROM THE ROTATOR, A FALSE REACTIVE RESULT MAY OCCUR. IF THE SERUM IS UNEVENLY SPREAD IN THE CIRCLE, THE ANTIGEN AND THE ANTIBODY MAY NOT MIX PROPERLY.