MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-28 for UNICEL? DXC 600 PRO SYNCHRON? CLINICAL SYSTEM A11810 manufactured by Beckman Coulter Inc..
[21012223]
A customer contacted beckman coulter inc. (bec) regarding a suppressed lactate (lact) result with rx abs hi (reaction absorbance high) flag generated by the unicel dxc 600 pro synchron clinical system on a neat sample draw from a patient that was intoxicated with ethylene glycol. The lab technician diluted the sample and the result yielded a value of 4. 1mmol/l. This value was reported outside of the laboratory around midnight of (b)(6) 2011. In the morning of (b)(6) 2011, the lab technician notified the biochemist of the results and the biochemist instructed the lab technician to rerun the sample with multiple dilutions. When the biochemist was notified that the patient was intoxicated with ethylene glycol, he reviewed the data and manually calculated the lact result which yielded a value of 2. 0 mmol/l and amended the original result. The biochemist concluded that glycolic acid could have interfered with the lactate reaction. The results provided by the customer are shown. Per the customer's laboratory reference intervals, both the original and amended results were within the normal ranges. There was no impact to patient treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[21236499]
Controls run before and after the incident were within established ranges. The root cause for this event is attributed to sample interference (ethylene glycol).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06225 |
| MDR Report Key | 2314049 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-23 |
| Date Mfgr Received | 2011-09-28 |
| Device Manufacturer Date | 2007-02-22 |
| Date Added to Maude | 2012-07-10 |
| 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. 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 BLVD. |
| 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 600 PRO SYNCHRON? CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CER |
| Date Received | 2011-10-28 |
| Model Number | DXC 600 PRO |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | SW VERSION 4.92 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-10-28 |