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 UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter, Inc..
[2311730]
A customer reported that erroneous, low aspartate aminotransferase (ast) results were generated on two unicel dxc 800 synchron systems for two patient samples over two days. This report is two of two and represents the erroneous ast result generated on a unicel dxc 800 synchron system with serial number (b)(4) for one patient sample on (b)(6) 2011. The initial ast result was low and below the assay's normal reference range. Upon subsequent repeat testing on the same and another instrument, the repeat results were higher, within the assay's normal reference range, concurred with each other, and were regarded as valid. The initial ast result was not reported outside of the laboratory and hence there were no reports of death, serious injury or modification to patient treatment associated or attributed to this event. The instrument ast quality control (qc) results during the time frame of the event recovered within the customer's established specifications however the customer indicated that the week prior they had experienced qc issues with this assay. The customer did not report any issues with other chemistries and the other chemistry results provided for this patient by the customer are not in question. The sample was a serum sample.
Patient Sequence No: 1, Text Type: D, B5
[9484802]
Service was dispatched on (b)(4) 2011 for this event. The field service engineer (fse) replaced the sample syringe and probe. The instrument was returned back into operation after completion of the necessary repairs. The root cause of this issue appears to be hardware related. Mdrs associated with this event: 2050012-2011-06976, 2050012-2011-06977.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06977 |
| MDR Report Key | 2336650 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2011-10-17 |
| Device Manufacturer Date | 2007-11-15 |
| 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 | UNICEL? DXC 800 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | CIT |
| Date Received | 2011-11-15 |
| 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |