MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-09-26 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter, Inc..
[2197524]
On (b)(6) 2011 customer reported that after performing the two week maintenance for the creatinine 3 (cre3) cup on the cx3 delta instrument, the cre3 cup began to leak creatinine reagent when primed. Customer reseated the photodetector, but it did not fix the leak, and customer then requested service for the instrument. No injuries were reported and no erroneous results were generated from this issue. Field service engineer (fse) advised customer to adjust the cre3 cup and total protein 3 (tp3) cup voltages. Customer then calibrated the instrument and ran a quality control check. No further problems have been reported.
Patient Sequence No: 1, Text Type: D, B5
[9328994]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05731 |
| MDR Report Key | 2264711 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-26 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-31 |
| Date Mfgr Received | 2011-08-31 |
| Device Manufacturer Date | 1996-01-24 |
| Date Added to Maude | 2012-06-08 |
| 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 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 SOUTH 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 CX3 DELTA |
| Generic Name | ANALYZER, CHEMISTRY, MICRO |
| Product Code | JJF |
| Date Received | 2011-09-26 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| 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 | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-26 |