MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-29 for UNICEL? DXC 800 PRO SYNCHRON? ACCESS? CLINICAL SYSTEM A10407 manufactured by Beckman Coulter.
[3495171]
A customer contacted beckman coulter (bec) reporting erroneously high hemoglobin a1c2 (hba1c2) patient results generated on the unicel dxc 800 pro synchron chemistry analyzer when the customer called bec to troubleshoot high quality control (qc) issues. No data was provided by the customer although attempts were made by bec. No actual date or numbers of patients involved were provided by the customer. Erroneous results were not amended. There was no report to date that there was any affect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[10796689]
Review of quality control (qc) data indicates high qc results after erroneous results were noted by the customer. The customer indicated that qc was out of range high greater than 4 standard deviation (sd) for both levels. Customer stated that qc results prior to the event were acceptable. A bec field service engineer (fse) was dispatched for this event. The fse found numerous hardware issues. The fse observed that the reagent mixer was mixing close to the edge of the cuvettes and aligned the mixer. Incidentally, the fse replaced the reagent and sample syringes due to binding movement. During re-calibration test, fse found cartridge chemistry (cc) sample probe pouring fluid into sample cups when down inside the cups during aspiration phase which caused the cups to overflow. The fse also replaced the cc sample probe, collar wash and finally the t-valve to resolve the dripping issue. Fse confirmed most likely the primary failure mode was the t-valve since the sample probe was pushing fluid back into the cups.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00373 |
| MDR Report Key | 3135857 |
| Report Source | 05,06 |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-01 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-05-01 |
| Device Manufacturer Date | 2005-11-19 |
| Date Added to Maude | 2013-08-07 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| 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? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | PDJ |
| Date Received | 2013-05-29 |
| Model Number | DXC 800 PRO |
| Catalog Number | A10407 |
| Lot Number | NA |
| ID Number | SW VERSION 5.0.13 |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-29 |