MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-04 for SYNCHRON? LX?I 725 SYSTEM 476501 manufactured by Beckman Coulter, Inc..
[2702212]
The customer reported an erroneously low creatine kinase (ck), result for one patient, involving synchron lxi 725 system. The customer stated analysis of the patient sample produced an initial result of 2. 9 u/l and did not correlate with previous results of 59 u/l and 68 u/l. Subsequent analysis of the patient sample recovered a result of 65. 8 u/l which was reported to the hospital. The erroneous result was not released out of the laboratory. There was no patient consequence or change in patient treatment associated with this event. Beckman coulter field service engineer (fse) went to the facility and assessed the instrument.
Patient Sequence No: 1, Text Type: D, B5
[9999265]
The field service engineer (fse) replaced cartridge chemistry (cc) sample probe, wash collar and the wash vacuum probe assembly to resolve the issue. The instrument conformed to the manufacturer's published performance specifications. Evaluation: wash collar; probe assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01542 |
| MDR Report Key | 2639345 |
| Report Source | 05,06 |
| Date Received | 2012-07-04 |
| Date of Report | 2012-06-09 |
| Date of Event | 2012-06-09 |
| Date Mfgr Received | 2012-06-09 |
| Device Manufacturer Date | 2004-08-06 |
| Date Added to Maude | 2012-10-22 |
| 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 | 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 | SYNCHRON? LX?I 725 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-07-04 |
| Model Number | NA |
| Catalog Number | 476501 |
| Lot Number | NA |
| ID Number | 4.9 |
| 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 | 2012-07-04 |