MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for CX/LX TBIL KIT 2 X 400 TEST 476861 manufactured by Beckman Coulter.
[90533426]
The customer informed customer technical support (cts) that a replacement of the tbil reagent with a different lot resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[90533427]
The customer reported obtaining false low total bilirubin (tbil) results, for an unknown number of patient samples, involving the unicel dxc 860i synchron access clinical system. The false low total bilirubin results were generated using tbil reagent, lot m703066. The false low tbil results were reported outside the laboratory and were questioned by the physician. The customer indicated the problem was regarding tbil samples with concentrations < 10 umol/l. The initial tbil results were recovering approximately 1. 5 - 2 umol/l and the repeat results were recovering 2-3 times higher. The customer repeated the patient samples using a different lot of tbil reagent, lot m705026 and the results were higher which were considered correct by the customer. (note: the customer received tbil reagent lot m705026 on a separate shipment from lot m703066) it is unknown if there was a change to patient treatment connected to this event. The customer was using bio-rad lyphochek assayed chemistry control, levels 1 (lot 26411) and level 2 (lot 26412) at the time of the event. Quality control for tbil was recovering close to the target assigned mean value for each level of control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050010-2017-00001 |
| MDR Report Key | 6948249 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2017-10-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2470 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CX/LX TBIL KIT 2 X 400 TEST |
| Generic Name | DIAZO COLORIMETRY, BILIRUBIN |
| Product Code | MQM |
| Date Received | 2017-10-13 |
| Model Number | NA |
| Catalog Number | 476861 |
| Lot Number | M703066 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2470 FARADAY AVE CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-13 |