MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-15 for SYNCHON CX DELTA CLINICAL SYSTEM 473513 manufactured by Beckman Coulter, Inc..
[2310908]
The customer reported that on (b)(4) 2011 an erroneous low urea nitrogen (bun3) result was generated from a synchon cx delta clinical system for one patient sample. The erroneous bun3 result was not released from the laboratory and hence there was no death, serious injury or modification to patient treatment associated or attributed to this event. Upon repeat on the same instrument, the bun3 result was higher, regarded as valid, and the initial result was amended. Instrument chemistry quality control (qc) results during the timeframe of this event recovered within customer established specifications. No sample handling/collection information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9468924]
Beckman coulter inc. Led the customer through instrument troubleshooting. The customer identified that the bun3 electrode had a scratch on the surface. The electrode was replaced and the instrument was returned back into operation after the completion of necessary and verified repairs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06975 |
| MDR Report Key | 2336629 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-10-17 |
| Date Mfgr Received | 2011-10-17 |
| Device Manufacturer Date | 2002-05-03 |
| Date Added to Maude | 2012-07-16 |
| 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 DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHON CX DELTA CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | CDL |
| Date Received | 2011-11-15 |
| Model Number | NA |
| Catalog Number | 473513 |
| 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 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |