MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-11 for UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter, Inc..
[2065807]
The customer reported that on (b)(6) 2011 an erroneously low phosphorus (phosm) result was generated from a unicel dxc 800 synchron system for one patient sample. The initial result was released from the laboratory and the patient received medical treatment because of the low result. The details of patient treatment are currently unknown. The sample was retested on the same instrument, as well as another instrument. The repeat results were higher. No sample collection/handling information was provided by the customer. Instrument phosm quality control results during the timeframe of the event were within customer specifications.
Patient Sequence No: 1, Text Type: D, B5
[9212069]
Beckman coulter inc. Customer technical services guided the customer through instrument troubleshooting. The customer performed a cup cleaning procedure, a lamp calibration, and an instrument calibration and assay quality control assessment. The customer advised that they would contact beckman coulter if the troubleshooting did not resolve the customer. No customer feedback reports has been received from this customer since the time of this event with a similar issue. Although adjustments were made to the instrument before returning it into service, a definitive root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04255 |
| MDR Report Key | 2200431 |
| Report Source | 05,06 |
| Date Received | 2011-08-11 |
| Date of Report | 2011-07-27 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-07-27 |
| Device Manufacturer Date | 2006-02-07 |
| Date Added to Maude | 2011-08-15 |
| 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 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 SYNCHRON? SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2011-08-11 |
| Model Number | NA |
| Catalog Number | A11812 |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-11 |