MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-25 for UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM A27318 manufactured by Beckman Coulter, Inc..
[2558533]
The customer reported that on (b)(6) 2012 erratic valproic acid (vpa) results were generated from a unicel dxc 600i synchron access clinical system for one patient sample. The same-sample vpa results tested on the unicel dxc 600i synchron access clinical system multiple times, generated varying results. The sample was subsequently tested on another instrument which generated consistent vpa results which were considered valid. The initial vpa result was reported out of the laboratory however, there were no reports of death, serious injury or modification to patient treatment associated or attributed to this event. An amended report was issued. Assay quality control (qc) results indicated that qc results met customer established specification prior to the event, however an elevated (four standard deviations above mean value) qc result was generated after the event. The sample was a serum sample the customer indicated that a "cuvette not dry at reagent dispense" error was generated on the day of the event.
Patient Sequence No: 1, Text Type: D, B5
[9544603]
Service was dispatched to the site on (b)(4) 2012 to address this issue. The field service engineer (fse) found multiple cuvettes failing water blank. The fse removed all cuvettes and manually cleaned outside of them and then performed a cuvette wash function. The fse checked the wash/vacuum probes for proper operation and alignments. The fse also replaced a mixer paddle and seven cuvettes. The fse adjusted the photometer due to elevated cuvette transmittance. Upon completion of a lamp alignment, cuvette centering, and lamp calibration, all the cuvettes had good transmittance and the water blanks cleared up. The instrument was returned back into service. Root cause is not known but hardware repairs have resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00244 |
| MDR Report Key | 2428200 |
| Report Source | 05,06 |
| Date Received | 2012-01-25 |
| Date of Report | 2012-01-02 |
| Date of Event | 2012-01-02 |
| Date Mfgr Received | 2012-01-02 |
| Device Manufacturer Date | 2009-09-30 |
| Date Added to Maude | 2012-08-08 |
| 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 600I SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | LFG |
| Date Received | 2012-01-25 |
| Model Number | NA |
| Catalog Number | A27318 |
| 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 | 2012-01-25 |