MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for FACSCANTO? 10 COLOR CONFIGURATION 657338 manufactured by Becton, Dickinson And Company, Bd Biosciences.
[137510619]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137510620]
This report represents patient 4 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 microsoft excel. The new file was sent to the forth party sunquest laboratory labaccess results workstation 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916837-2019-00104 |
| MDR Report Key | 8380466 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2016-06-21 |
| Date Added to Maude | 2019-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
| Manufacturer Street | 2350 QUME DRIVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FACSCANTO? 10 COLOR CONFIGURATION |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2019-02-28 |
| Catalog Number | 657338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
| Manufacturer Address | 2350 QUME DRIVE SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-28 |