KIT BD MAX ENTERIC VIRAL PANEL
Report
- Report Number
- 3007420875-2022-00016
- Event Type
- Malfunction
- Date Received
- March 31, 2022
- Date of Event
- October 1, 2019
- Report Date
- April 1, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THIS MDR SHOULD BE CONSIDERED CANCELLED. IT WAS DETERMINED THAT THIS MALFUNCTION OCCURRED WHILE PERFORMING COMMERCIAL PANEL SAMPLES TESTING.
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL ¿FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " REPORT OF FALSE POSITIVES WITH 443985 - LOT NUMBER - KIT LOT # 9163712.
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL ¿FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " REPORT OF FALSE POSITIVES WITH 443985 - LOT NUMBER - KIT LOT # 9163712.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1128785 | KIT BD MAX ENTERIC VIRAL PANEL | GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX | PCH | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 443985 | 9163712 | 00382904439859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |