KIT BD MAX CHECK-POINTS CPO IVD

Additional Manufacturer Narrative

H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX CHECK-POINTS CPO IVD (CATALOG#: 278102), LOT: 0302034 WAS PERFORMED BY CHECK-POINTS, PRODUCT MANUFACTURER. INVESTIGATION WAS PERFORMED BY REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE DATA RECEIVED FROM CUSTOMER AND VERIFICATION OF THE COMPLAINTS HISTORY. MANUFACTURING RECORDS REVIEW SHOWS THAT THE LOT HAS BEEN TESTED ACCORDING TO SPECIFICATIONS AND MEET ALL ACCEPTANCE CRITERIA. THE CUSTOMER COMPLAINED ABOUT 2 SAMPLES (B7 AND B8) BEING REPORTED AS NEGATIVE WHILE POSITIVE PCR AMPLIFICATION CURVES WERE OBSERVED. ONE RUN (4602) WAS PROVIDED BY THE CUSTOMER. CHECK-POINTS ANALYSIS OF THE RUN REVEALED THAT BOTH SAMPLES HAD A LATE AMPLIFICATION AND CROSSED THE FLUORESCENCE THRESHOLD AFTER THE CYCLE CUTOFF. THEREFORE, THEY ARE REPORTED AS NEGATIVE RESULT DESPITE A VISIBLE LATE PCR AMPLIFICATION. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX CHECK-POINTS CPO IVD LOT 0302034. THE ROOT CAUSE FOR DISCREPANT RESULTS WAS NOT IDENTIFIED BUT ENVIRONMENTAL OR VERY LOW LEVEL OF TARGETED ORGANISM ARE SUSPECTED. CHECK-POINTS AND BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED AS THERE IS NO INDICATIONS OF A MALFUNCTION OF THE CHECK-POINTS PRODUCT ASSAY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CHECK-POINTS CPO IVD FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CUSTOMER SENT ME A RUN WITH 3 CPO TESTS. TWO OF THEM SHOW POSITIVE AMPLIFICATION BUT NEGATIVE END RESULTS. B7 IN BD MAX CPO 62 585/630 IS VERY HIGH AND B8 IN BD MAX CPO 62 530/565 SHOWS ALSO GOOD AMPLIFICATION".

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, ANTIMICROBIAL RESISTANCE MARKER, DIRECT SPECIMEN.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CHECK-POINTS CPO IVD FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CUSTOMER SENT ME A RUN WITH 3 CPO TESTS. TWO OF THEM SHOW POSITIVE AMPLIFICATION BUT NEGATIVE END RESULTS. B7 IN BD MAX CPO 62 585/630 IS VERY HIGH AND B8 IN BD MAX CPO 62 530/565 SHOWS ALSO GOOD AMPLIFICATION".