MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-04 for UNICEL? DXC 600I SYNCHRON ? CHEMISTRY ANALYZER A27318 manufactured by Beckman Coulter Inc..
[1715060]
A customer contacted beckman coulter inc. (bci) in regards to an erroneous high salicylates results on one patient generated by the unicel dxc 600i synchron chemistry analyzer. The erroneous result was reported out of the laboratory. The sample was repeated and lower result was obtained. Amended report was initiated. Patient was admitted to the hospital based on the false high result. Unknown if any treatment was administered.
Patient Sequence No: 1, Text Type: D, B5
[8952672]
Qc was run prior to the event and the results were within established ranges. The customer found the sample probe and collar wash contained gel from the serum separator tube. The customer replaced the parts and requested service. A bci field service engineer (fse) performed the followings: cleaned the cartridge chemistry (cc) sample probe and collar wash. Replaced the cc level sense bead and performed alignment. Ran sample and confirmed the correct results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00542 |
| MDR Report Key | 2008151 |
| Report Source | 06 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-02-07 |
| Date of Event | 2011-02-05 |
| Date Mfgr Received | 2011-02-07 |
| Device Manufacturer Date | 2007-08-30 |
| Date Added to Maude | 2011-03-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON ? CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKJ |
| Date Received | 2011-03-04 |
| Model Number | DXC 600I |
| Catalog Number | A27318 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Hospitalization | 2011-03-04 |