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 2018-09-20 for SYNCHRON SYSTEMS AQUA CAL 1 LX AQUA CALIBRATOR LEVEL 1 471288 manufactured by Beckman Coulter.
[122168307]
A beckman coulter applications specialist was sent to the customer site. A new lot of aquacal level 1 was used to resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122168308]
The customer reported erroneously low sodium (na) results on their unicel dxc 600 pro synchron system. The results were reported outside of the laboratory. The customer stated that quality control (qc) recovered within specifications prior to the event. There was no change to patient treatment in association with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050010-2018-01000 |
| MDR Report Key | 7896408 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-06-20 |
| Date Facility Aware | 2018-06-20 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2018-09-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2470 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS AQUA CAL 1 |
| Generic Name | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| Product Code | JIX |
| Date Received | 2018-09-20 |
| Model Number | LX AQUA CALIBRATOR LEVEL 1 |
| Catalog Number | 471288 |
| Lot Number | 72935498 |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-20 |