MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-14 for UNICEL? DXC 600 SYNCHRON? SYSTEM A10405 manufactured by Beckman Coulter.
[4486815]
A customer reported their dxc 600 instrument generated false high k (potassium) and cl (chloride) results for 3 patient samples. Na (sodium), co2 (carbon dioxide) and calc (calcium) results were suppressed (no results generated) for these same samples. The results were not reported out of the laboratory so there was no impact to patient treatment. When the issue was noticed, samples were repeated. It is unknown if the repeats were performed on the same or another instrument.
Patient Sequence No: 1, Text Type: D, B5
[11841760]
A field service engineer was not dispatched. The customer support representative assisted the customer over the phone. The customer found the end of line #24 (ise buffer reagent) was not connected at the ratio pump. The customer trimmed and reconnected the line, resolving the issue. (b)(4). Customer was able to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2014-00200 |
| MDR Report Key | 3749752 |
| Report Source | 05,06 |
| Date Received | 2014-04-14 |
| Date of Report | 2014-03-27 |
| Date of Event | 2014-03-27 |
| Date Mfgr Received | 2014-03-27 |
| Device Manufacturer Date | 2005-09-24 |
| Date Added to Maude | 2014-06-06 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MZV |
| Date Received | 2014-04-14 |
| Model Number | NA |
| Catalog Number | A10405 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-04-14 |