MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-03 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter, Inc..
[19580021]
Customer called to report that the synchron cx3 delta creatinine module erroneously generated one high patient result. The patient was first drawn at 5 a. M. , and then again at 8 a. M. , after which the discrepant result was discovered. The field service engineer (fse) inspected the instrument and found that the creatinine cup was not draining properly. The fse replaced the reaction cup, the preheater, and the stir motor to address the issue. The fse then verified proper instrument performance to ensure that the services performed effectively resolved the instrument issue. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves. There was no death, injury or change to patient treatment attributed to or associated with this complaint. The results were not reported out of the laboratory; therefore, patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[19786720]
The root cause of the issue is attributed to the creatinine cup not draining properly. The issue was resolved with the repairs performed by the field service engineer. Customer has not called back to report any further issues relating to this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00844 |
| MDR Report Key | 2515563 |
| Report Source | 05,06 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-03-16 |
| Date Mfgr Received | 2012-03-16 |
| Device Manufacturer Date | 2005-10-25 |
| Date Added to Maude | 2012-09-06 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2012-04-03 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| ID Number | SW VERSION 4.0 |
| 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 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-03 |