MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-07-18 for UNICEL? DXC 600 SYNCHRON? SYSTEM A11810 manufactured by Beckman Coulter.
[3597444]
The customer reported obtaining an erroneously high phy (phenytoin) result of 158 umol/l for one (b)(6) female on the unicel dxc 600 synchron system. Subsequent testing of the patient's sample on the original analyzer and on an alternate dxc 600 analyzer produced lower results of 47. 5 umol/l and 48 umol/l respectively. The customer did not question or repeat any other analytes for this patient. The customer stated that fluid was found on the sides of the reagent cartridges within the reagent carousel compartment of the instrument while troubleshooting for the high phy result. The customer stated that some of the loaded cartridges also had fluid inside compartment c of the cartridge. The leak was contained within the reagent compartment and the customer was not exposed to the leak. Qc (quality control) results prior to the event were within the laboratory's established specifications. Qc was not run by the customer following the event.
Patient Sequence No: 1, Text Type: D, B5
[10946195]
A beckman coulter fse (field service engineer) was dispatched to the customer's site. The fse primed the cc (cartridge chemistry) reagent probes and replaced the reagent probe b waste valve assembly. The fse then loaded new reagents onto the instrument, calibrated all cc assays, and ran qc for all assays. The fse stated that all control recovery was within specifications and no further leaks were observed. Failure mode of the event is attributed to the waste solenoid valve.
Patient Sequence No: 1, Text Type: N, H10
[17618049]
An amended report of 47. 5 umol/l was issued out of the laboratory after the repeat result was obtained. There was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[17745927]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00490 |
| MDR Report Key | 3235652 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-26 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2007-05-03 |
| Date Added to Maude | 2013-10-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | DKH |
| Date Received | 2013-07-18 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | SW VERSION 5.0.13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-18 |