MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-22 for SYNCHRON? CX5 DELTA CLINICAL SYSTEM 468243 manufactured by Beckman Coulter Inc..
[1800638]
A customer contacted beckman coulter inc. (bci) in regards to twenty seven (27) erroneous high and one (1) erroneous low tg (triglyceride) results that were generated by the synchron cx5 delta chemistry analyzer and were reported out of the laboratory. The samples were repeated and results within range were obtained. An amended report was initiated on all 28 samples. A separate mdr 2050012-2010-01229 was submitted for the malfunction portion of this event. This mdr is for the patient who was treated.
Patient Sequence No: 1, Text Type: D, B5
[8901135]
Prior to the event, tg was calibrated and qc results were within the labs established ranges. A bci field service engineer (fse) was dispatched and cleaned the canisters and replaced the hydro check valves. The fse replaced hardware, flushed the waste system as well as the sample and reagent probes. Fse performed carryover test which passed. No further occurrences were reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01266 |
| MDR Report Key | 1904808 |
| Report Source | 05 |
| Date Received | 2010-11-22 |
| Date of Report | 2010-11-18 |
| Date of Event | 2010-10-20 |
| Date Mfgr Received | 2010-10-20 |
| Device Manufacturer Date | 1999-05-21 |
| Date Added to Maude | 2011-04-20 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CX5 DELTA CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGX |
| Date Received | 2010-11-22 |
| Model Number | CX5 DELTA |
| Catalog Number | 468243 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-22 |