MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-16 for UNICEL DXC 800 PRO SYNCHRON SYSTEM A11812 manufactured by Beckman Coulter.
[4574961]
The customer reported incorrect acetaminophen (actm) results were generated by a unicel dxc 800 pro synchron system. This mdr reports the event that occurred on (b)(6) 2014. On (b)(6) 2014, a unicel dxc 800 pro synchron system generated false positive actm results for one patient sample. The positive result was reported out of the laboratory and the patient received treatment; the exact details of treatment were not disclosed. The original patient sample and two redrawn samples were retested on the same instrument and an alternate instrument; the unicel dxc 800 pro synchron system continued to generate false positive actm results while the alternate instrument generated negative actm results. Correct results were later sent to the physician. Quality control (qc) failures were exhibited prior to and after the event for multiple cartridge chemistries, excluding actm. Upon troubleshooting the instrument, the customer found a leak from a cartridge chemistry (cc) reagent probe. Information on personal protective equipment worn by the instrument operator and information on whether injuries occurred in connection with the leak were not provided by the customer. After the event, the instrument generated error messages involving the cc cuvette and failed actm calibration with multiple calibration errors.
Patient Sequence No: 1, Text Type: D, B5
[12128449]
A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument. The fse replaced the wash collar solenoid valve, which resolved the leak. Associated mdr: 2050012-2014-00335.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2014-00336 |
| MDR Report Key | 3938149 |
| Report Source | 05,06 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-06-16 |
| Device Manufacturer Date | 2008-10-30 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| 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 800 PRO SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2014-07-16 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID Number | SW VERSION 5.3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-16 |