BD MAX¿ ENTERIC PARASITE PANEL
Report
- Report Number
- 3007420875-2023-00034
- Event Type
- Malfunction
- Date Received
- May 1, 2023
- Date of Event
- February 20, 2023
- Report Date
- May 2, 2023
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- PCH
- UDI-DI
- 00382904429607
- PMA / PMN Number
- K143648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6. THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC PARASITE PANEL ASSAY (B)(4) LOTS 1138119, 2172819 AND 2110891 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ ENTERIC PARASITE PANEL ASSAY INDICATED THAT LOTS 1138119, 2172819 AND 2110891 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED JAGGED CURVES CAUSING POSITIVE RESULTS OF GLAMB AND CRYPTO TARGETS FOR TEN SAMPLES TESTED BETWEEN 2021-12-14 AND 2023-02-20, WITH THREE DIFFERENT KITS LOTS 1138119, 2172819 AND 2110891. OF THOSE SAMPLES, TWO WERE POSITIVE FOR GLAMB AND CRYPTO TARGETS, WHILE FOUR WERE POSITIVE ONLY FOR GLAMB AND FOUR WERE POSITIVE ONLY FOR CRYPTO TARGETS. THE CUSTOMER DID NOT MENTION IF THE SAMPLES WERE REPEATED. CUSTOMER PROVIDED TEN RUNS FILE FROM INSTRUMENT CT1566 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON ALL TEN SAMPLES. ANALYSIS OF THE PCR CURVES REVEALED STEP DISLOCATION IN THE RAW PCR SIGNAL IN EVERY CHANNEL, RESULTING IN POSITIVE RESULTS ONLY FOR GLAMB TARGETS OR FOR GLAMB AND CRYPTO TARGETS. IT IS UNLIKELY THAT THESE ATYPICAL CURVES ARE DUE TO TRUE AMPLIFICATIONS AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL OR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE TEN ISSUES OCCURRED OVER A PERIOD OF TWO YEARS, USING THREE DIFFERENT KIT LOTS, SUGGESTING THAT THE ISSUE IS NOT LINKED TO SPECIFIC REAGENTS. AN INVESTIGATION THROUGH AN INSTRUMENT SERVICE TICKET IS ALSO ONGOING. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC PARASITE PANEL ASSAY LOTS 1138119, 2172819 AND 2110891. 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 PLAN (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.
D2A: COMMON DEVICE NAME:GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM. INITIAL REPORTER PHONE: (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.
REPORT 17 OF 20. IT WAS REPORTED THAT BD MAX¿ ENTERIC PARASITE PANEL DUE TO JAGGED CURVES SOMETIMES INSTRUMENT FLAGS POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO JAGGED CURVES, EPP SOMETIMES GIVES FALSE POSITIVE RESULTS MOSTLY FOR GIARDIA LAMBLIA (475 CHANNEL).
REPORT 17 OF 20. IT WAS REPORTED THAT BD MAX¿ ENTERIC PARASITE PANEL DUE TO JAGGED CURVES SOMETIMES INSTRUMENT FLAGS POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO JAGGED CURVES, EPP SOMETIMES GIVES FALSE POSITIVE RESULTS MOSTLY FOR GIARDIA LAMBLIA (475 CHANNEL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275892 | BD MAX¿ ENTERIC PARASITE PANEL | SEE H.10 | PCH | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 442960 | 2172819 | 00382904429607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |