MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for TOTAL BILIRUBIN REAGENT CX/LX TBIL KIT 2 X 400 TEST 476861 manufactured by Beckman Coulter.
[131012774]
A beckman coulter field service engineer (fse) was dispatched and evaluated the device. The field service engineer (fse) used a new cartridge of the same lot of total bilirubin (tbil) reagent to resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131012775]
The customer reported receiving erroneous low patient results for total bilirubin (tbil) on the unicel dxc 660i synchron access clinical system. The erroneous results were reported outside of the lab. There was no change in patient treatment in association with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050010-2018-01001 |
| MDR Report Key | 8182708 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-24 |
| Date Facility Aware | 2018-11-24 |
| Date Mfgr Received | 2018-11-24 |
| Device Manufacturer Date | 2018-08-06 |
| Date Added to Maude | 2018-12-19 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER CARLSBAD |
| Manufacturer Street | 2470 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOTAL BILIRUBIN REAGENT |
| Generic Name | DIAZO COLORIMETRY, BILIRUBIN |
| Product Code | CIG |
| Date Received | 2018-12-19 |
| Model Number | CX/LX TBIL KIT 2 X 400 TEST |
| Catalog Number | 476861 |
| Lot Number | M808018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |