KIT BD MAX ENTERIC VIRAL PANEL
Report
- Report Number
- 1119779-2021-02014
- Event Type
- Malfunction
- Date Received
- December 22, 2021
- Date of Event
- September 25, 2021
- Report Date
- March 7, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- PCH
- UDI-DI
- 00382904439859
- PMA / PMN Number
- K181427
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL (REF. 443985) LOTS 1146537, 1209714 AND 1251639 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC VIRAL PANEL INDICATED THAT LOTS 1146537, 1209714 AND 1251639 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED OF SUSPECTED FALSE POSITIVE RESULTS FOR SOME SAMPLES. THE DATABASE FROM INSTRUMENT (B)(6) AS WELL AS 10 RUNS WERE PROVIDED FOR THE INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE RUNS RECEIVED. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. MOST OF THE POSITIVE RESULTS WERE STRONG POSITIVE, HOWEVER, SOME LATE AND LOW POSITIVE RESULTS WERE ALSO FOUND (2 SAMPLES). LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. DATABASE ANALYSIS REVEALED AN INCREASE OF POSITIVE ROV STATUSES IN TIME, NOT ASSOCIATED WITH A SPECIFIC KIT LOT. ANALYSIS SHOWS ALSO THAT IN ADDITION TO THIS INCREASE OF ROV POSITIVE STATUSES, THE RESULTS SUGGESTED AN INCREASE OF SAMPLES LOAD. TESTING SPECIMENS WITH SUCH A HIGH LOAD COULD CAUSE ENVIRONMENTAL OR CROSS CONTAMINATION DURING THE SAMPLE PREPARATION. THIS IS SUSPECTED OF HAVING CAUSED PART OF THE CUSTOMER ISSUE. FOR SEVEN OF THE ADV POS RESULTS, THE AMPLIFICATION CURVES OF THE ADV TARGET STARTED INCREASING AT THE SAME CT, AND PRESENTED THE SAME SHAPE, AS THOSE OF THE ROV TARGET. THESE RESULTS SUGGEST A CROSSTALK PHENOMENON (BLEED OVER) OF THE FAM CHANNEL TO THE VIC CHANNEL. THIS INFORMATION WAS TRANSFERRED TO THE BD TECHNICAL SERVICE FOR FURTHER INVESTIGATION. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX ENTERIC VIRAL PANEL PRODUCTS LOTS 1146537, 1209714 AND 1251639. THE ROOT CAUSE WAS NOT IDENTIFIED BUT A CONTAMINATION BY THE CUSTOMER, SAMPLE AT OR NEAR THE LOD AND AN INSTRUMENT CROSS TALK ARE SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THIS INFORMATION WAS TRANSFERRED TO THE BD TECHNICAL SERVICE FOR FURTHER INVESTIGATION. BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN SINCE NO REAGENT ISSUE WAS IDENTIFIED. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: D.4. LOT NUMBERS: 1209714, 1146537, 1251639; EXPIRATION DATES: 2022-11-26, 2022-11-19, 2023-02-25; MANUFACTURE DATES: 2021-01-20, 2021-01-20, 2021-01-20.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: NA.
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " ENTERIC VIRAL PANEL IS SHOWING POSITIVE RESULTS THAT ARE NEGATIVE UPON REPEAT WITH OTHER ASSAY. "
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " ENTERIC VIRAL PANEL IS SHOWING POSITIVE RESULTS THAT ARE NEGATIVE UPON REPEAT WITH OTHER ASSAY. "
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " ENTERIC VIRAL PANEL IS SHOWING POSITIVE RESULTS THAT ARE NEGATIVE UPON REPEAT WITH OTHER ASSAY. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1958703 | KIT BD MAX ENTERIC VIRAL PANEL | GASTROINTESTINAL PATHOGEN PANEL | PCH | BECTON, DICKINSON & CO. (SPARKS) | 443985 | SEE H.10. | 00382904439859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |