BD MACRO-VUE¿ RPR CARD TEST
Received Mar 14, 2024 · Event occurred Feb 20, 2024
Report 2647876-2024-00051 · MDR key 18904316
Device
Generic name
Antigens, Nontreponemal, All
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
275005
Lot number
3009503
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 WHILE TESTING WITH BD MACRO-VUE¿ RPR CARD TEST, NON REACTIVE RESULTS WERE OBTAINED ON SAMPLES THAT PREVIOUSLY TESTED AS REACTIVE AT ANOTHER FACILITY WITH A DIFFERENT RPR TEST. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD MACRO-VUE¿ RPR CARD TEST, NON REACTIVE RESULTS WERE OBTAINED ON SAMPLES THAT PREVIOUSLY TESTED AS REACTIVE AT ANOTHER FACILITY WITH A DIFFERENT RPR TEST. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: MATERIAL: 275005 BATCH 3009503. CUSTOMER REPORTED: BD RPR DISCORDANT RESULTS VS RAPID TEST FROM ANOTHER MANUFACTURER. SEROLOGY TEST, VISUAL INSPECTION AND BATCH RECORD REVIEW WAS PERFORMED TO RETENTION SAMPLE. NO RETURNED GOODS RECEIVED; NO PHOTO WAS PROVIDED. RETENTION SAMPLE RESULTS: SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED FOR PERFORMANCE USING THREE (3) SERA PANEL NUMBERS OF EACH REACTIVITY. CONTROL LOT (3275853) CUSTOMER BATCH NUMBER (3009503). SERUM NO'S. 1, 4, 9: ALL LOTS SHOWED NEGATIVE RESULTS. SERUM NO. 15: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1 TO 1:4 AND REACTIVE MINIMAL AT 1:8. SERUM NO. 19: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1, REACTIVE MINIMAL AT 1:2 TO 1:4. SERUM NO. 20: ALL LOTS SHOWED REACTIVE RESULTS AT 1:1, REACTIVE MINIMAL AT 1:2. SERUM NO'S; 24, 25 AND 33: ALL LOTS SHOWED REACTIVE MINIMAL RESULTS AT 1:1TO 1:2 AND NON-REACTIVE AT 1:4. BATCH 3009503 WAS USED FOR CAP SYPHILIS SEROLOGY SURVEY, G-A 2023, SHOWING GOOD RESULTS ON G-01 TO G-05. SATISFACTORY RESULTS WERE OBTAINED FOR PRODUCT PERFORMANCE, COMPLAINT UNCONFIRMED BASED OF RETENTION SAMPLE RESULTS AND BATCH HISTORY RECORD REVIEW. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. BD ID/AST PLANT QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS FOR THIS DEFECT, INCLUDING CHANGES IN SEVERITY AND RATE. H3 OTHER TEXT : SEE H.10.