MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-30 for SYNCHRON LXI 725 SYSTEM A15642 manufactured by Beckman Coulter, Inc..
[2745296]
The customer reported that a false low quality control (qc) result for b-type natriuretic peptide (bnp) and creatine kinase-mb isoenzyme (ck-mb), respectively were generated from a synchron lxi 725 system. The customer also reported receiving a sys-flagged "no value" result for a cardiac troponin (accutni) level one quality control result as well as a level three ck-mb qc result after a "sample carousel motion error" message was posted to the instrument event log. Repeat qc results recovered within the customer's established limits. No patient results were affected by this event and hence there was no death, serious injury or modification to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9885768]
Service was not dispatched to the site for this event. Beckman coulter inc. Assessment of the instrument's event log and archive data file indicated the erroneous quality control results were consistent with the instrument aspirating the sample from the incorrect rack position. The instrument software recognized a sample carousel motion error occurred and recovered, but not all affected results were flagged. This issue is under further investigation by beckman coulter inc. A definitive root cause has not been determined to date for this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01412 |
| MDR Report Key | 2592831 |
| Report Source | 05,06 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-05-11 |
| Date Mfgr Received | 2012-05-11 |
| Device Manufacturer Date | 2005-01-11 |
| Date Added to Maude | 2012-09-26 |
| 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 | 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, INC |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON LXI 725 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-05-30 |
| Model Number | NA |
| Catalog Number | A15642 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION I5.9.00 |
| 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 | 2012-05-30 |