MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-11 for UNICEL? DXC 800 SYNCHRON? SYSTEM A11812 manufactured by Beckman Coulter.
[3998111]
The customer reported false low k (potassium) and cl (chloride) results were generated when using the unicel dxc 800 synchron system. The customer stated 10 samples were affected. Na (sodium) was suppressed, i. E. No results were generated. The test results were not reported out of the lab. The samples were repeated on another instrument and those results reported. There was no death, injury or affect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[11506758]
Qc (quality control) was run prior to the event and was within the laboratory's established ranges. Qc was not run after the event. Proservice shows that the customer had successfully calibrated na (sodium) at 10:55 pm the evening prior on (b)(6) 2013. Starting at 4:17 am on (b)(6) 2013, calibrations started to fail. Multiple attempts through 8:30 am failed. Hotline had the customer perform the twice weekly maintenance, at which time the customer found the tubing on the top of the sample probe was loose and reseated it. Calibration then passed. The field service engineer (fse) evaluated the instrument and found that the top section of the flowcell was clogged and greenish in color. The fse cleaned it with dilute bleach. The fse also replaced the co2 (carbon dioxide) membrane. These actions were incidental to the reported problem. Identified failure mode: failure mode was loose tubing at the top of the mc sample probe (473435). Tightening the tubing fitting resolved the issue. The dirty flowcell was not the cause of the calibration failures and sudden erroneous results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00809 |
| MDR Report Key | 3515834 |
| Report Source | 05,06 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-11-18 |
| Date of Event | 2013-11-18 |
| Date Mfgr Received | 2013-11-18 |
| Device Manufacturer Date | 2006-06-08 |
| Date Added to Maude | 2014-03-25 |
| 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 | 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 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2013-12-11 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID Number | 5.0 |
| 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 | 2013-12-11 |