BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
Report
- Report Number
- 1119779-2020-00207
- Event Type
- Malfunction
- Date Received
- July 14, 2020
- Date of Event
- June 18, 2020
- Report Date
- September 14, 2020
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- QJR
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0121402; MEDICAL DEVICE EXPIRATION DATE: 10/31/2020; DEVICE MANUFACTURE DATE: 4/30/2020; MEDICAL DEVICE LOT #: 0120606; MEDICAL DEVICE EXPIRATION DATE: 10/30/2020; DEVICE MANUFACTURE DATE: 4/29/2020; MEDICAL DEVICE LOT #: 0120611; MEDICAL DEVICE EXPIRATION DATE: 10/30/2020; DEVICE MANUFACTURE DATE: 4/29/2020. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# (B)(4)). LOTS 0121402, 0120606 & 0120611 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. DATA PROVIDED BY THE CUSTOMER REVEALED THAT THE LOTS INVOLVED IN THE ISSUES DID NOT MATCH LOT 0121409 ENTERED IN THE COMPLAINT. THEREFORE, ONLY THE LOTS FOUND IN THE DATA WERE ANALYZED. MANUFACTURING REVIEW OF THE BD SARS-COV-2 REAGENT KIT LOTS 0121402, 0120606, 0120611 WERE AS EXPECTED. MOREOVER, THE QC RESULTS OF THE THREE KIT LOTS WERE WITHIN THE TRENDS. HOWEVER, ANALYSIS OF THE TRENDS OF SHOWED A HIGH LEVEL OF BACKGROUND NOISE IN FAM (N1) AND CY5 (N2) CHANNELS. MANUFACTURING REVIEW OF THE BD MAX¿ EXK¿ TNA-3 KIT LOTS 0125991, 0125893 AND 0128082 SHOWS THAT ONE EMPTY WELL WAS OBTAINED FOR LOT 0125991, PROBABLY ATTRIBUTABLE TO THE 175¿L TIPS (ARTICLE 500030941) INCLUDED IN THE KIT. THESE 175 L TIPS WERE IDENTIFIED AS A POTENTIAL SOURCE OF EMPTY OR PARTIALLY FILLED WELLS (CAPA (B)(4)). QC RESULTS WERE WITHIN THE TRENDS FOR THE LAST TWELVE MONTHS. CUSTOMER COMPLAINED FOR A HIGH RATE OF POSITIVE RESULTS WITH A LOW LEVEL OF FLUORESCENCE. CUSTOMER PROVIDED SEVEN RUN FILES FOR ANALYSIS (RUN 2909, 2910, 2915, 3203, 3205, 3215 & 3228). ONLY THE PDF OF EACH RUN WAS PROVIDED, LIMITING THE ANALYSIS. BD RUN ANALYSIS ALLOWED TO ASSOCIATE ALMOST ALL THE POSITIVE RESULTS FROM THE PDF RUNS PROVIDED, EXCEPT TWO (B5 (TARGET N2) AND B9 (TARGET N1)). MOREOVER, THREE PDF DID NOT CONTAIN FALSE POSITIVE RESULTS CORRESPONDING TO THE COMPLAINT DESCRIPTION (RUNS 2909, 3205 AND 3215). RUNS 2910 LANE B1 AS WELL AS RUN 3228 LANES A12 AND B11 CORRESPOND TO TRUE AMPLIFICATION WITH TYPICAL CURVES SHAPE AND SUGGEST TRUE POSITIVE SAMPLES AT THE LIMIT OF DETECTION, OR A CROSS CONTAMINATION. RUN 3203 A6 DID NOT SHOW A TYPICAL AMPLIFICATION CURVE IN THE CY5 CHANNEL. INDEED, THE CURVE IS WAVY, AND GENERATED A CT SCORE AND CONSEQUENTLY A POSITIVE STATUS. THIS SAMPLE DOES NOT CORRESPOND TO A TRUE AMPLIFICATION. THERE IS A KNOWN PRODUCT ISSUE CAUSED BY SIGNAL DRIFT IN THE CY5 CHANNEL, WITH THE N2 TARGET CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE IN THE CURVES, RESULTING IN FALSE POSITIVE RESULTS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA# (B)(4)) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED. FOR SAMPLE B10 IN RUN 2910 AS WELL AS SAMPLES A1, A3 AND A7 IN RUN 2915, IT WAS NOT POSSIBLE TO ANALYZE THE CURVES. INDEED, SINCE THESE RUNS CONTAIN HIGH POSITIVE SAMPLES, THE SCALE IS TOO HIGH TO SEE THE SHAPE OF THE CURVES OF THE DISCREPANT SAMPLES. POSSIBLE EXPLANATIONS FOR THESE POSITIVE RESULTS COULD BE LOW POSITIVE SAMPLES, CONTAMINATION, BACKGROUND NOISE, OR A PCR CURVE GLITCH. THERE IS COMPLAINT TREND FOR FALSE POSITIVE RESULTS FOR THE BD MAX SARS-COV-2 REAGENTS LOTS. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA# (B)(4)) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE FOR ASSAY BACKGROUND NOISE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED. NO ADDITIONAL CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME. THE RETAIN MATERIAL DID NOT NEED TO BE TESTED SINCE IT WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. A GROSS PRODUCT CONTAMINATION WOULD HAVE BEEN DETECTED BY THE FINAL QC TEST, WHICH IS NOT THE CASE. MOREOVER, INVESTIGATION RESULTS SUGGEST A COMBINATION OF TRUE BUT LOW AMPLIFICATION OR CONTAMINATION AND BACKGROUND NOISE OR A GLITCH CAUSED BY THE TIPS. UPDATE RISK MANAGEMENT FILE: THERE IS NO NEED TO UPDATE THE REAGENT RISK MANAGEMENT FILE. POTENTIAL CAUSE SUCH AS LIMIT OF DETECTION, CONTAMINATION & BACKGROUND NOISE HAVE ALREADY BEEN IDENTIFIED AND DOCUMENTED INTO THE RISK MANAGEMENT FILE DOCUMENT BALTRM-MAXSARSCOV2-APH V.D. CURRENT RISK ASSESSMENT REMAINS RELEVANT.
IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737971 | BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM | SARS-COV-2 REAGENT KIT | QJR | BECTON, DICKINSON & CO. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |