BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
Report
- Report Number
- 1119779-2021-01823
- Event Type
- Malfunction
- Date Received
- November 16, 2021
- Date of Event
- October 1, 2021
- Report Date
- December 17, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QJR
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT (REF (B)(4) ) LOT 1251611 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM INDICATED THAT LOT 1251611 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SEVERAL LOW N1 POSITIVE / N2 NEGATIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT 1251611, WHICH WERE NEGATIVE WHEN REPEATED. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. WITHOUT MORE INFORMATION, BD WAS UNABLE TO INVESTIGATE FURTHER, AND THE CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. OVERALL, BASED ON THE INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD SARS-COV-2 REAGENTS FOR BD MAX LOT 1251611. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS H3 OTHER TEXT : SEE H.10.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT FOR N1 WAS PRODUCED. THE SAMPLE WAS RETESTED FROM THE ORIGINAL VIRAL TRANSPORT TUBE ON THE BD MAX WITH NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANT RESULTS FOR N1". "CUSTOMER REPORTING SEVERAL ALLEGED FALSE POSITIVE/DISCREPANT RESULTS OVER THE PAST FEW WEEKS ON THE BD COV-2 ASSAY, CATALOG# 44500301, LOT# 1251611". "CUSTOMER HAS SEVERAL SAMPLES THAT INITIALLY TESTED POSITIVE (N1 TARGET ONLY) THAT WERE NEGATIVE WHEN RE-TESTED ON THE BD MAX (SPECIMEN REPEATED FROM ORIGINAL VIRAL TRANSPORT TUBE). THE PATIENTS BEING TESTED HAVE BEEN ASYMPTOMATIC PATIENTS THAT ARE BEING SCREENED BEFORE SURGERY.".
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT FOR N1 WAS PRODUCED. THE SAMPLE WAS RETESTED FROM THE ORIGINAL VIRAL TRANSPORT TUBE ON THE BD MAX WITH NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANT RESULTS FOR N1". "CUSTOMER REPORTING SEVERAL ALLEGED FALSE POSITIVE/DISCREPANT RESULTS OVER THE PAST FEW WEEKS ON THE BD COV-2 ASSAY, CATALOG# 44500301, LOT# 1251611" "CUSTOMER HAS SEVERAL SAMPLES THAT INITIALLY TESTED POSITIVE (N1 TARGET ONLY) THAT WERE NEGATIVE WHEN RE-TESTED ON THE BD MAX (SPECIMEN REPEATED FROM ORIGINAL VIRAL TRANSPORT TUBE). THE PATIENTS BEING TESTED HAVE BEEN ASYMPTOMATIC PATIENTS THAT ARE BEING SCREENED BEFORE SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1718897 | BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM | SARS-COV-2 REAGENT KIT | QJR | BECTON, DICKINSON & CO. (SPARKS) | 1251611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |