MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-30 for UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM A11810 manufactured by Beckman Coulter, Inc..
[2351335]
The customer contacted beckman coulter, inc. (bci) to report that their unicel dxc 600 synchron clinical system gave erroneously low calcium (calc) results for more than 25 patient samples. The erroneous results were reported out of the lab. It is unknown if there were any changes to patient treatment as a result of this event. There were no reports of death or serious injury. The customer stated that the ion selective electrode (ise) system is calibrated and a quality control (qc) is run routinely every 24 hours. Prior to the event, the calc qc results were within the lab's established ranges. The system operators noticed that calc results were low. The operator's repeated all of the samples run over the previous 24 hours. The samples were repeated on the lab's second analyzer. Some results were higher and amended reports were issued on more than 25 patient samples. The nursing staff was notified of the error as soon as it was detected. A single medwatch report was filed in 2009 for this event. This is report 8 of 25 medwatch reports filed for this event for patient 8 of 25 patients.
Patient Sequence No: 1, Text Type: D, B5
[9309845]
A bci field service engineer (fse) evaluated the system and replaced the sodium (na) reference electrode and the carbon bridge. This reportable event was identified during a retrospective review of complaints conducted between january 1, 2008 and october 23, 2010 for additional reportable events. This mdr represents event 8 of 25 reported by this customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05790 |
| MDR Report Key | 2285247 |
| Report Source | 05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2009-08-11 |
| Date of Event | 2009-08-11 |
| Date Mfgr Received | 2009-08-11 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2011-12-05 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM |
| Product Code | JFP |
| Date Received | 2011-09-30 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |