MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-06 for SYNCHRON? LX20 PRO ANALYZER 476100 manufactured by Beckman Coulter Inc..
[16742244]
A customer contacted beckman coulter inc. (bec) stating the synchron lx20 pro analyzer phosphorous module (phosm) generated 24 erroneously low patient results from (b)(6) 2011. This report is 6 of 7 reports being sent for this event and documents the patient results on (b)(6) 2011. The erroneous results were reported outside of the laboratory but there was no affect to patient treatment with regard to this event.
Patient Sequence No: 1, Text Type: D, B5
[16938663]
A field service engineer (fse) went on-site (b)(6) 2011 and found that the stirrer was not spinning. Fse replaced the motor and performed maintenance on the module. Repair was verified per established procedures and results meet published performance specifications. The following mdrs are related to this event: 2050012-2011-05826; 2050012-2011-05827; 2050012-2011-05828; 2050012-2011-05829; 2050012-2011-05830; 2050012-2011-05831.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05832 |
| MDR Report Key | 2280971 |
| Report Source | 06 |
| Date Received | 2011-10-06 |
| Date of Report | 2011-09-06 |
| Date of Event | 2011-09-05 |
| Date Mfgr Received | 2011-09-06 |
| Device Manufacturer Date | 2002-08-06 |
| Date Added to Maude | 2012-06-13 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| 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 | SYNCHRON? LX20 PRO ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| Product Code | CEO |
| Date Received | 2011-10-06 |
| Model Number | LX20 PRO |
| Catalog Number | 476100 |
| Lot Number | NA |
| ID Number | SW VERSION 4.7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-06 |