MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-27 for SYNCHRON? LX20 PRO CLINICAL SYSTEM 476100 manufactured by Beckman Coulter Inc..
[1325015]
A customer contacted beckman coulter inc. (bci) regarding falsely high theophylline (the) results generated by the synchron lx20 pro clinical system. A patient's sample was tested neat for the and a result of ">40ug/ml" was obtained. The sample was diluted 1:1 and the result of ">80ug/ml" was reported out of the lab and questioned by the physician. The specimen was then rerun neat and repeated results were 4. 4/4. 1. A corrected report was issued. During investigation, it was discovered that another patient's sample tested for the three days before was also affected. The initial result was ">40ug/ml" and "<4ug/ml" upon dilution 1:1. The results were not reported out of the lab. The specimen was then rerun neat and a result of "<2ug/ml" was reported out of the lab. Unknown if treatment was initiated or withheld based upon the false high result reported for patient 1, but the physician questioned the result.
Patient Sequence No: 1, Text Type: D, B5
[8417455]
Per customer, qc before and after the event was within lab established ranges. A field service engineer (fse) was dispatched:upon inspection, a carryover with the sample system was noted, and the fse verified that the sample probe and mixer were not being properly cleaned. The fse replaced and cleaned parts, performed alignments, and verified acceptable instrument performance. Upon recur, the issue could affect other chemistries including potentially pivotal chemistries, and treatment could be initiated or withheld based upon the erroneous result. The carryover from the sample probe and mixer may have contributed to this event. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2009-00112 |
| MDR Report Key | 1516131 |
| Report Source | 05 |
| Date Received | 2009-10-27 |
| Date of Report | 2009-10-27 |
| Date of Event | 2009-10-10 |
| Date Mfgr Received | 2009-10-10 |
| Device Manufacturer Date | 1999-08-12 |
| Date Added to Maude | 2009-10-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD P.O. BOX 8000 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 200 S. KRAEMER BOULEVARD P.O. BOX 8000 |
| Manufacturer City | BREA 92822800 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92822 8000 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? LX20 PRO CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KLS |
| Date Received | 2009-10-27 |
| Model Number | LX20 PRO |
| Catalog Number | 476100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 200 S KRAEMER BLVD. BREA CA 92822800 US 92822 8000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-27 |