MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-14 for UNICEL DXC 600 PRO SYNCHRON SYSTEM A11810 manufactured by Beckman Coulter.
[17581363]
The customer obtained an erroneously elevated acetaminophen (actm) result for one patient sample involving the unicel dxc 600 pro synchron system. The sample generated an initial result greater than the analytical range for actm assay. The customer diluted the sample and repeated it on the same unicel dxc 600 pro synchron system. The repeat result for the diluted sample was higher than the initial result for neat sample. The diluted repeat result was reported outside the laboratory. The patient was treated for an acetaminophen overdose by administration of acetylcysteine. The physician questioned the result because the patient was not exhibiting high actm symptoms. The sample was repeated again and the instrument generated a low actm result. The laboratory does not know what effect this treatment had on the patient. The customer sent the lithium heparin specimen to a neighboring hospital and tested the sample on a dxc instrument and obtained a low actm result which verified the previous repeat result. Quality control was within laboratory's established ranges prior to and after the event.
Patient Sequence No: 1, Text Type: D, B5
[17793617]
Failure mode is unknown. No other samples or assays were affected; sample specific event. Quality control was within laboratory's established ranges prior to and after event. No service visit was initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2015-00008 |
| MDR Report Key | 4419726 |
| Report Source | 05,06 |
| Date Received | 2015-01-14 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-12-19 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2010-03-26 |
| Date Added to Maude | 2015-01-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821800 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 8000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 600 PRO SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2015-01-14 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 5.3.05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821800 US 92821 8000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-14 |