MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-08 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER. DXC800 PRO A11812 manufactured by Beckman Coulter Inc..
[1839940]
A customer contacted beckman coulter inc. (bci) in regards to suppressed acetaminophen (actm) result generated on the unicel dxc 800 pro synchron chemistry analyzer. The customer diluted the sample with saline and retested the sample which yielded a result of 0. 2 ug/ml. The customer reported a result of < 10 ug/ml out of the laboratory. A redrawn sample was tested on an alternate unit and a result of 2. 5 ug/ml was obtained. Amended report was initiated. Unknown if treatment was withheld or administered.
Patient Sequence No: 1, Text Type: D, B5
[8841821]
Controls were run before the event and the results were within the established ranges. The customer ran controls post the event and suppressed qc l-3 results were obtained. The customer recalibrated the instrument and reran controls which were within the established ranges. Service was not requested. Customer technical support (cts) informed the customer that actm cis does not instruct to dilute the sample with suppressed error result, since it is unknown if the sample was actually high or low. Cts advised the customer to replace the reagent, calibrate, rerun patient sample. Operator error is the root cause for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00388 |
| MDR Report Key | 1981811 |
| Report Source | 06 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-01-17 |
| Date of Event | 2011-01-17 |
| Date Mfgr Received | 2011-01-17 |
| Device Manufacturer Date | 2007-09-12 |
| Date Added to Maude | 2012-01-25 |
| 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 | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KREAMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KREAMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER. |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | LDP |
| Date Received | 2011-02-08 |
| Model Number | DXC800 PRO |
| Catalog Number | A11812 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2011-02-08 |