BD MAX¿ CHECK-POINTS CPO
Received Mar 3, 2022 · Event occurred Feb 3, 2022
Report 3007420875-2022-00002 · MDR key 13664302
Device
Generic name
See H.10.
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
278102
Lot number
1040789
Product problems
- False Negative Result
- False Negative Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, ANTIMICROBIAL RESISTANCE MARKER, DIRECT SPECIMEN MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ CHECK-POINTS CPO, A FALSE NEGATIVE RESULT WAS OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE SAMPLE WAS CLASSIFIED AS NEGATIVE EVEN THOUGH THE FLUORESCENCE CURVE WENT UP TO A VALUE OF 4000 AT THE END OF A RUN.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX CHECK-POINTS CPO IVD (REF. (B)(4)) LOT 1040789 WAS PERFORMED BY CHECK-POINTS, PRODUCT MANUFACTURER. INVESTIGATION WAS PERFORMED BY REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER DATA AND VERIFICATION OF THE COMPLAINTS HISTORY. BD MAX CHECK-POINTS CPO LOT #1040789 DOES NOT CORRESPOND TO CHECK-POINT CPO RELEASE DOCUMENTATION THEREFOR CHECK-POINT WAS NOT ABLE TO VERIFY MANUFACTURING OR QC RECORDS. THE CUSTOMER COMPLAINED FOR ONE SAMPLE THAT WAS CLASSIFIED AS NEGATIVE EVEN THOUGH THE FLUORESCENCE CURVE WENT UP TO A VALUE OF 4000 AT THE END OF A RUN. RUN 5324 AND 5327 WERE PROVIDED FOR ANALYSIS. THE RUN #5324 CONTAINED 24 SAMPLES TESTED WITH VARIOUS ASSAY. SAMPLE IN A6 LANE WAS TESTED WITH BD MAX CHECK-POINTS CPO ASSAY AND THE RESULT WAS NEGATIVE. SAMPLE CROSSES THE FLUORESCENCE THRESHOLD OF 400 BETWEEN CYCLE 35 AND CYCLE 36 WHICH IS AFTER ASSAY CUT-OFF VALUE. RUN 5327 SAMPLE B3 YIELDED A NEGATIVE TEST RESULT. PCR CURVES ANALYSIS SHOWED NO INDICATION OF ABNORMALITY. THE SAMPLE PROCESSING CONTROL (SPC) WERE WITHIN SPECIFICATION RANGE. IT WAS NOTED THAT THE CUSTOMER USES AN OLDER ADF VERSION (V1) WHILE THERE IS AN UPDATED VERSION OF THE ADF (V2) AVAILABLE SINCE (B)(6) 2019. USES OF VERSION 1 ADF IS AN OFF-LABEL USE OF THE PRODUCT. ADF VERSION VERIFICATION OF SEVERAL OTHER ASSAY USED BY THE CUSTOMER INDICATES THAT HE IS USING ASSAY VERSIONS THAT ARE NOT UP TO DATE. THIS INFORMATION WAS TRANSFERRED TO THE BD TECHNICAL SERVICE FOR FURTHER VERIFICATION. BASED ON AVAILABLE INFORMATION, THE RESULTS INTERPRETATION OF BOTH SAMPLES IS CORRECT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX CHECK-POINTS CPO IVD LOT 1040789. THE ROOT CAUSE FOR DISCREPANT RESULTS WAS NOT IDENTIFIED. 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. CHECK-POINTS PRODUCT MANUFACTURER AND BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN.
Description of Event or Problem
IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ CHECK-POINTS CPO, A FALSE NEGATIVE RESULT WAS OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE SAMPLE WAS CLASSIFIED AS NEGATIVE EVEN THOUGH THE FLUORESCENCE CURVE WENT UP TO A VALUE OF 4000 AT THE END OF A RUN.