N
Patient 1
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 8380465
- MDR report key
- 8380465
- Report number
- 2916837-2019-00103
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-25
- Date received
- 2019-02-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- BDX BRETT WILKO
- Address
- 9450 SOUTH STATE STREET SANDY UT 84070 US
- Phone
- 801-801-8015
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FACSCANTO? 10 COLOR CONFIGURATION | FLOW CYTOMETER | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | OYE | 657338 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-28 | 0 | 1. O |
Event Narratives#
D
Patient 1
THIS REPORT REPRESENTS PATIENT 1 OF 4: IT WAS REPORTED THAT WHILE PERFORMING TESTS WITH A FACSCANTO? 10 COLOR CONFIGURATION, PATIENT DATA WAS EXPORTED FROM THE INSTRUMENT AS A .CSV FILE (COMMA SEPARATED VARIABLES FILE) IN AN UNUSUAL FORMAT. REPORTEDLY, THE EXPORTED FILE DID NOT PROPERLY SEPARATE INDIVIDUAL DATA ENTRIES WITH COMMAS INTO SEPARATE COLUMNS OF THE FILE AND ALL DATA POINTS WERE PLACED IN THE SAME COLUMN. THE LAB TECHNICIAN CONVERTED THE ORIGINAL FILE INTO A TAB DELIMITED .TXT FILE (TEXT FILE) USING THE THIRD PARTY APPLICATION (B)(4). THE NEW FILE WAS SENT TO THE FOURTH PARTY (B)(4) WHERE ERRONEOUSLY CALCULATED RESULTS WERE ASSIGNED TO FOUR SEPARATE PATIENTS. THIS RESULTED IN PATIENTS BEING ASSIGNED RESULTS FOR THE FOLLOWING TESTS THAT WERE INCONSISTENT WITH RESULTS FROM THE FACSCANTO? 10 COLOR CONFIGURATION INSTRUMENT GENERATED REPORTS: CD3+ % (PERCENTAGE); CD3+CD4+ % (PERCENTAGE); CD3+CD4+ ABS (ABSOLUTE VALUE); CD3+CD8+ % (PERCENTAGE); CD4+CD8+ RATIO; CD16/56+ % (PERCENTAGE); CD3-CD19+ % (PERCENTAGE). GENERALIZED RESULTS WERE PROVIDED HIGHLIGHTING SIGNIFICANT DIFFERENCES BETWEEN THE RESULTS REPORTED BY THE FACSCANTO? 10 COLOR CONFIGURATION AND THE RESULTS THAT WERE ASSIGNED TO PATIENTS THROUGH THE HOSPITAL?S WORKFLOW AS WELL AS A .CSV FILE CONTAINING MIS-FORMATTED DATA. NO SPECIFIC INFORMATION WAS PROVIDED REGARDING WHICH PATIENTS RECEIVED WHICH TEST RESULTS AND WHAT IMPACT THIS HAD ON THEIR COURSE OF TREATMENT. ON FOLLOW UP, IT WAS NOT POSSIBLE TO OBTAIN INFORMATION LINKING SPECIFIC PATIENT IDENTIFIERS TO SPECIFIC TEST RESULTS. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS LED TO A MISDIAGNOSIS OR A DETERIORATION OF THE PATIENTS? CONDITION.