MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-12 for SYNCHRON CX9 SYNCHRON CX9 SYSTEM 473541 manufactured by Beckman Coulter, Inc..
[205975]
Customer states that when running the synchron cx9, incorrect results for various analytes were generated due to a hardware error with the sample mixer. Customer claims that the mixer failure did not generate an error message to alert the operator. No injury has been reported due to this event. Field service replaced the sample mixer and resolved the users issue. Qa engineering could not duplicate the customer claim of no error messages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-1999-00004 |
| MDR Report Key | 250752 |
| Report Source | 05,06 |
| Date Received | 1999-11-12 |
| Date of Report | 1999-11-09 |
| Date of Event | 1999-09-06 |
| Date Mfgr Received | 1999-09-09 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 1999-11-23 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | REGINA O'MEARA |
| Manufacturer Street | 200 S. KRAEMER BLVD P.O. BOX 8000 |
| Manufacturer City | BREA CA 926228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 926228000 |
| Manufacturer Phone | 7149614489 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX9 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJG |
| Date Received | 1999-11-12 |
| Model Number | SYNCHRON CX9 SYSTEM |
| Catalog Number | 473541 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 242933 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 200 S. KRAEMER BLVD. BREA CA 928228000 US |
| Baseline Brand Name | SYNCHRON CX9 |
| Baseline Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Baseline Model No | SYNCHRON CX9 SY |
| Baseline Catalog No | 473541 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-12 |