MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-30 for UNICEL? DXC 800 PRO SYNCHRON? ACCESS? CLINICAL SYSTEM A11812 manufactured by Beckman Coulter.
[3614150]
A customer contacted beckman coulter (bec) reporting that the unicel dxc 800 pro synchron chemistry analyzer generated a false low phenytoin (phy) result for one (1) patient sample of < 0. 1 ug/ml. The erroneous result was reported out of the laboratory. Due to the false low phy result, the physician administered additional phy to the patient. The physician later questioned the result and the laboratory facility reran the original sample both on the original dxc and an alternate dxc instrument. The repeated results yielded values of 23. 4 ug/ml and 23. 3 ug/ml, respectively. The customer confirmed that only the patient's phy result was erroneous. No other analytes were questioned. No additional information regarding impact on patient and/or patient treatment has been provided, by the customer, at this time.
Patient Sequence No: 1, Text Type: D, B5
[10978284]
Quality control (qc) was run prior to and after the event and was within laboratory established ranges. The sample was collected in a plasma separator tube and centrifuged for only 4 minutes at 6000 rpm. The customer indicated no issues with the instrument. The customer stated that the low result is consistent with a short sample and this event was isolated to one (1) patient sample. There was no evidence of an instrument malfunction. No evidence of device malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00532 |
| MDR Report Key | 3255371 |
| Report Source | 05,06 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-07-08 |
| Date of Event | 2013-07-07 |
| Date Mfgr Received | 2013-07-08 |
| Device Manufacturer Date | 2008-10-30 |
| Date Added to Maude | 2013-07-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | DKH |
| Date Received | 2013-07-30 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-30 |