MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-15 for UNICEL DXC 600 PRO SYNCHRON SYSTEM A11810 manufactured by Beckman Coulter.
[87310118]
A beckman coulter field service engineer (fse) was dispatched and evaluated the instrument. The fse was unable to determine a failure mode and proactively performed an ise (ion-selective electrode) decontamination procedure and replaced the mc (module chemistry) sample probe. Although the failure mode is unknown, the malfunction of the mc sample probe could not be ruled out.
Patient Sequence No: 1, Text Type: N, H10
[87310119]
The customer alleged two (2) erroneously high k (potassium) patient results were generated on their unicel dxc 600 pro synchron system. The customer stated the patient sample results were not reported outside of the laboratory and there was no impact to patient treatment. There were no calibration or quality control (qc) issues observed prior to the event. A review of the provided k calibration passed and qc (quality control) recoveries were within instrument control ranges on the event date. However, synchron control level 1 recoveries on the event date exceeded the k total precision claim.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2017-00026 |
| MDR Report Key | 6870541 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-15 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-22 |
| Device Manufacturer Date | 2012-11-13 |
| Date Added to Maude | 2017-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149313796 |
| 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 600 PRO SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CEM |
| Date Received | 2017-09-15 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Brand Name | UNICEL DXC 600 PRO SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2017-09-15 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |