BD VERITOR SYSTEM RSV ASSAYS
Report
- Report Number
- 3014704491-2023-00157
- Event Type
- Injury
- Date Received
- May 1, 2023
- Date of Event
- April 3, 2023
- Report Date
- May 31, 2023
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- GQG
- UDI-DI
- 00382902560425
- PMA / PMN Number
- K133140
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E.6 INITIAL REPORTER EMAIL: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE AND FALSE NEGATIVE RESULT WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # (B)(6), BATCH NUMBER (B)(6). BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BASED ON THE PROVIDED INFORMATION, IT WAS UNDERSTOOD THAT THE CUSTOMER RECEIVED ONE FALSE POSITIVE AND ONE FALSE NEGATIVE RESULT WITH VERITOR. THE RESULTS WERE COMPARED WITH A SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR). UPON FOLLOW-UP WITH THE CUSTOMER IN RELATION TO THE PROCEDURE USED, IT WAS IDENTIFIED THAT A POSSIBLE FACTOR THAT COULD AFFECT THE RESULT WAS THAT THE CUSTOMER USED REPACKAGED SALINE SOLUTION AND MAXIMUM TIME OF REFERRAL OF SAMPLES TO LSP OF 72 HOURS, SPECIALIST REPORTED THAT THERE WAS NO KNOWN STABILITY OF THE PCR TEST IN SALINE SOLUTION. IT IS RECOMMENDED NOT TO USE REPACKAGE SALINE SOLUTION. A BATCH HISTORY RECORD (BHR) REVIEW AND RETENTION TESTING WERE PERFORMED ON BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUES WERE FOUND. NO PHYSICAL SAMPLES WERE RETURNED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. CUSTOMER SENT IMAGES OF VERITOR TEST RESULTS AND PCR ANALYSIS REPORT WHICH CONFIRMED THE REPORTED ISSUE. THIS COMPLAINT WAS CONFIRMED BASED ON THE DATA PROVIDED BY THE CUSTOMER. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR THE REPORTED ISSUE.
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM RSV ASSAYS A FALSE POSITIVE WAS OBTAINED CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF 1 FALSE POSITIVE RESULT IN VERITOR PLUS (RESPIRATORY SYNCYTIAL VIRUS-RSV) COMPARED TO A PCR STUDY CARRIED OUT BY THE CITY'S PUBLIC HEALTH LABORATORY. LOT: 1123929 SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM RSV ASSAYS A FALSE POSITIVE WAS OBTAINED CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF 1 FALSE POSITIVE RESULT IN VERITOR PLUS (RESPIRATORY SYNCYTIAL VIRUS-RSV) COMPARED TO A PCR STUDY CARRIED OUT BY THE CITY'S PUBLIC HEALTH LABORATORY. LOT: 1123929 SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702286 | BD VERITOR SYSTEM RSV ASSAYS | NA | GQG | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 256042 | 1123929 | 00382902560425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR | Female | Hospitalization |