MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-23 for UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter.
[3742168]
The customer reported obtaining erroneously high acetaminophen (actm) and salicylate (saly) results for one emergency room patient sample from a unicel dxc 800 synchron system. The customer stated that an actm result of >300 ug/ml and a saly result of >100 mg/dl were generated for the patient. Both results were greater than the analytical range of the assay. The customer repeated the original sample on the same instrument, and similar high results were obtained and reported out of the laboratory. The patient was then airlifted to another hospital for a redraw. The customer confirmed that there was no affect to patient treatment. It is unknown of why the patient was in the emergency room. No patient demographics are available, and there was no data provided by the customer for review. The customer stated that quality control (qc) results prior to the event were within the laboratory's established ranges. The customer is running qc once every 24 hours. The customer repeated the sample on an alternate analyzer and both actm and saly results were less than the analytical range. The customer then ran qc on the original dxc 800 instrument and obtained out of instrument range high qc results. The customer loaded fresh reagents for both actm and saly, and the qc results passed within the established ranges.
Patient Sequence No: 1, Text Type: D, B5
[11227968]
A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse concluded that the reagent was not the source of the issue. The fse evaluated the cartridge chemistry (cc) side of the instrument and determined that the cause of the event was attributed to a partially occluded cc sample probe with a clot. The fse replaced the cc sample probe to resolve the issue. Failure mode of the event is use error. The instrument's instructions for use (ifu) indicates that samples should be free of all visible fibrin. Clots could coat or plug the sample probes, flow cell, chemistry modules, electrolyte injection cup (eic), or cuvette wash station leading to instrument malfunction and/or short sampling. Results: clot in cc sample probe.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00618 |
| MDR Report Key | 3363667 |
| Report Source | 05,06 |
| Date Received | 2013-09-23 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-08-30 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2005-12-08 |
| Date Added to Maude | 2013-09-24 |
| 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 800 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2013-09-23 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID Number | SW VERSION 5.0.13 |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-23 |