MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-04 for SYNCHRON CX3 DELTA CLINICAL SYSTEM 467501 manufactured by Beckman Coulter, Inc..
[19203276]
The customer contacted beckman coulter, inc (bec) to report that an erroneously high blood urea nitrogen (bun) result was generated on their synchron cx3 delta clinical system. The customer reported that the erroneous result was not reported outside of the lab. There was no impact to pt treatment associated with this event. The customer reported that quality control (qc) results were within the lab's established ranges prior to the event. The customer reassayed the pt sample on another analyzer in the lab as well as repeating the analysis on the original analyzer. A lower expected result was obtained.
Patient Sequence No: 1, Text Type: D, B5
[19444536]
No other tests performed on the pt samples were found to be discrepant. A field service engineer (fse) was dispatched to the customer's site. A cracked bun electrode was replaced. No other hardware issues were observed with the analyzer. This reportable event was identified during a retrospective review conducted between january 1, 2008 and october 23, 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07218 |
| MDR Report Key | 2345755 |
| Report Source | 05,06 |
| Date Received | 2011-11-04 |
| Date of Report | 2009-06-23 |
| Date of Event | 2009-06-23 |
| Date Mfgr Received | 2009-06-23 |
| Date Added to Maude | 2012-07-12 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA CLINICAL SYSTEM |
| Product Code | JJF |
| Date Received | 2011-11-04 |
| Model Number | NA |
| Catalog Number | 467501 |
| Lot Number | NA |
| ID Number | SV 4.7 |
| 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 | 2011-11-04 |