BD MAX¿ ENTERIC VIRAL PANEL
Report
- Report Number
- 3007420875-2022-00014
- Event Type
- Malfunction
- Date Received
- March 29, 2022
- Date of Event
- February 28, 2022
- Report Date
- March 31, 2022
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- 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
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL (REF. 443985) LOTS 1270277 AND 1293481 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 1270277 AND 1293481 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH BD MAX¿ ENTERIC VIRAL PANEL KITS FROM LOTS 1293481 AND 1270277 FOR SEVERAL SAMPLES. FOLLOWING RECOMMENDATIONS FROM BD, THE CUSTOMER SWABBED 24 AREAS. THE SWABS WERE TESTED IN A DIFFERENT LABORATORY, USING BD MAX¿ INSTRUMENT (CM0050). AMONG THE 24 AREAS SWABBED, 10 OBTAINED A POSITIVE RESULT FOR THE ROV TARGET. CUSTOMER QUESTIONED THESE RESULTS SINCE TWO OUTER BOXES AS WELL AS ONE BLANK SBT WERE POSITIVE. THE DATABASE FROM INSTRUMENT CT2329 AND RUN 1550, AS WELL AS DATABASE FROM CM0050 AND RUN 112 WERE PROVIDED FOR THE INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE ROV POSITIVE SAMPLES IN THE DATA PROVIDED. ANALYSIS OF ALL PCR CURVES SHOWS LATE BUT TRUE AMPLIFICATIONS WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS. 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. CONSIDERING THIS SITE IS KNOWN TO HAVE HAD PREVIOUS ROV CONTAMINATION, AND SINCE THE SAMPLES INVOLVED IN THE CURRENT INVESTIGATION ARE ENVIRONMENTAL MONITORING SAMPLES, THE MOST PROBABLE CAUSE FOR THE CURRENT ISSUE REMAINS CONTAMINATION IN THE CUSTOMER'S ENVIRONMENT. MOREOVER, SUCH RESULTS COULD EXPLAIN WHY THE OUTER BOX OR THE BLANK SBT ARE CONTAMINATED. CUSTOMER COMPLAINED ALSO FOR THREE SAMPLES (A2, A3 AND A5) WHICH ARE POSITIVE FOR TARGETS OTHER THAN ROV, IN RUN 1550, ON BD MAX¿ INSTRUMENT CT2329. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ON THESE SAMPLES. FIRST, SAMPLE LANE A2, WHICH IS POSITIVE FOR THE ADV TARGET, SUGGESTS A CROSSTALK PHENOMENON OF THE FAM CHANNEL TO THE VIC CHANNEL. A BD INSTRUMENT QUALITY ENGINEER WAS ALREADY INVESTIGATING CT2329 DECK A ( INSTRUMENT SERVICE TICKET OPENED) TO ASSESS A POTENTIAL CROSSTALK ISSUE ON THE INSTRUMENT. THE SECOND SAMPLE (LANE A5), POSITIVE FOR THE NOV TARGET, SHOWS AN ATYPICAL CURVE IN EVERY CHANNEL, RESULTING IN THE POSITIVE NOV TARGET RESULT WITHOUT AFFECTING THE OTHER CHANNELS. AN ISOLATED BUT NOT IDENTIFIED EVENT HAVE OCCURRED. THE LAST SAMPLE A5 FOR WHICH THE CUSTOMER COMPLAINED, SHOWS A LATE BUT TRUE AMPLIFICATION OF THE SAV TARGET, WITHOUT ANOMALY. SUCH LOW POSITIVE RESULTS CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMENS BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING SAMPLE PREPARATION AT THE CUSTOMER SITE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, VARIOUS POTENTIAL ROOT CAUSES HAVE BEEN IDENTIFIED AS CONTRIBUTING TO THE CUSTOMER ISSUE SUCH AS INSTRUMENT CROSS TALK, ONE ISOLATED UNKNOWN EVENT AND CONTAMINATION AT THE CUSTOMER SITE. OVERALL, NO REAGENTS ISSUE IS SUSPECTED. 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 LOTS 1270277 AND 1293481. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, AN INSTRUMENT ISSUE (CROSS TALK), ONE ISOLATED UNKNOWN EVENT AND ENVIRONMENTAL CONTAMINATIONS CAN EXPLAIN THE CUSTOMER POSITIVES RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC VIRAL PANEL THE CUSTOMER RECEIVED A FALSE POSITIVE RESULTS AT A CUSTOMER SITE. ADDITIONAL TESTING IN A LAB ALSO PRODUCED FALSE POSITIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STRANGE POSITIVE RESULTS WITH THE EVP KIT AFTER SWABBING AT THE CUSTOMER SITE. AFTER OBTAINING A LOT OF FALSE POSITIVE RESULTS FOR EVP, I WENT INTO THE LAB AND SWABBED 24 AREAS. (LIST OF AREAS IS IN THE RELATED TAB). THE ACCESSION NUMBER ON THE REPORT INDICATES WHERE I'VE BEEN SWABBING. I SWABBED WITH 221000 ESWAB COLLECTION KIT BY PUTTING THE SWAB IN THE SBT/SWABBING THE AREA/PUTTING THE SWAB INTO THE SBT AGAIN. THE SBT WAS RECAPPED WITH THE SAME CAP AND ANALYZED IN THE LAB OF EREMBODEGEM THE SAME DAY. RESULTS: OUT OF 24 SAMPLES 10 SAMPLES ARE POSITIVE FOR ROTAVIRUS. THIS COULD MEAN THAT THERE IS A GREAT POSSIBILITY OF CONTAMINATION. WHAT I FIND VERY STRANGE IS THAT : SAMPLE "20 NOTHING" IS ALSO POSITIVE, AS I DIDN'T EVEN OPEN THE SBT AT THE CUSTOMER SITE. IT IS A BLANC. SAMPLE "22 EVP CARTON BOX" IS ALSO POSITIVE FOR ROV: I SWABBED THE OUTER BOX OF THE EVP KIT . SAMPLE "23 SARS CARTON BOX" IS ALSO POSITIVE FOR ROV: I SWABBED THE OUTER BOX OF THE SARS-COV-2/FLU KIT . I STRONGLY HAVE MY DOUBTS ABOUT THESE RESULTS. I USED THE BD MAX IN THE LAB OF EREMBODEGEM ((B)(6)) TO TEST THE SWABS (BD MAX CM0050).¿
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC VIRAL PANEL THE CUSTOMER RECEIVED A FALSE POSITIVE RESULTS AT A CUSTOMER SITE. ADDITIONAL TESTING IN A LAB ALSO PRODUCED FALSE POSITIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STRANGE POSITIVE RESULTS WITH THE EVP KIT AFTER SWABBING AT THE CUSTOMER SITE. AFTER OBTAINING A LOT OF FALSE POSITIVE RESULTS FOR EVP, I WENT INTO THE LAB AND SWABBED 24 AREAS. (LIST OF AREAS IS IN THE RELATED TAB). THE ACCESSION NUMBER ON THE REPORT INDICATES WHERE I'VE BEEN SWABBING. I SWABBED WITH 221000 ESWAB COLLECTION KIT BY PUTTING THE SWAB IN THE SBT/SWABBING THE AREA/PUTTING THE SWAB INTO THE SBT AGAIN. THE SBT WAS RECAPPED WITH THE SAME CAP AND ANALYZED IN THE LAB OF EREMBODEGEM THE SAME DAY. RESULTS: OUT OF 24 SAMPLES 10 SAMPLES ARE POSITIVE FOR ROTAVIRUS. THIS COULD MEAN THAT THERE IS A GREAT POSSIBILITY OF CONTAMINATION. WHAT I FIND VERY STRANGE IS THAT : - SAMPLE "20 NOTHING" IS ALSO POSITIVE, AS I DIDN'T EVEN OPEN THE SBT AT THE CUSTOMER SITE. IT IS A BLANC. - SAMPLE "22 EVP CARTON BOX" IS ALSO POSITIVE FOR ROV: I SWABBED THE OUTER BOX OF THE EVP KIT - SAMPLE "23 SARS CARTON BOX" IS ALSO POSITIVE FOR ROV: I SWABBED THE OUTER BOX OF THE SARS-COV-2/FLU KIT I STRONGLY HAVE MY DOUBTS ABOUT THESE RESULTS I USED THE BD MAX IN THE LAB OF EREMBODEGEM (BELGIUM) TO TEST THE SWABS (BD MAX CM0050)¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50823 | BD MAX¿ ENTERIC VIRAL PANEL | GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM | PCH | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 443985 | 1293481 | 00382904439859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |