MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-01-15 for UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DXC 880I A59102 manufactured by Beckman Coulter, Inc..
[2564429]
The customer reported that their unicel dxc800i analyzer generated one erroneous high digoxin result (3. 3 ng/ml). The erroneous result was not reported out of the laboratory; hence patient treatment was not impacted. The customer ran controls before testing the patient samples for dign, and the qc results were within established ranges. The sample was repeated on an alternate instrument and lower result (1. 7 and 1. 8 ng/ml) were obtained and confirmed. On (b)(4) 2011, a field service engineer (fse) performed: a pvt-3 (carryover test) and pvt-5 (precision/accuracy test). Qc and precision run for dign and the results were within ranges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00171 |
| MDR Report Key | 2416470 |
| Report Source | 01,06 |
| Date Received | 2012-01-15 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-12-16 |
| Date Mfgr Received | 2011-12-16 |
| Device Manufacturer Date | 2009-02-10 |
| Date Added to Maude | 2012-08-03 |
| 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 | MRS. 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 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LFM |
| Date Received | 2012-01-15 |
| Model Number | DXC 880I |
| Catalog Number | A59102 |
| Lot Number | N/A |
| ID Number | SW 4.92 |
| 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 | 2012-01-15 |