MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-07 for SYNCHRON? LX20 PRO CLINICAL SYSTEM 476100 manufactured by Beckman Coulter Inc..
[14886349]
The customer contacted beckman coulter, inc. (bci) regarding false low phenytoin (phy) results that were generated by the synchron lx20 pro clinical system. The erroneous results were reported outside of the lab. Upon rerun, the results were higher and were amended. Unknown if treatment was initiated or withheld based upon the low results.
Patient Sequence No: 1, Text Type: D, B5
[15518177]
Qc run prior to the event was within the lab's established ranges, but after the event the qc was out of range high. A field service engineer (fse) was dispatched. The fse replaced multiple parts. A clear root cause for this event has not been determined. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00153 |
| MDR Report Key | 1652564 |
| Report Source | 05 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-04-07 |
| Date of Event | 2010-03-12 |
| Date Mfgr Received | 2010-03-13 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2010-08-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? LX20 PRO CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2010-04-07 |
| Model Number | LX20 PRO |
| Catalog Number | 476100 |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-07 |