MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-23 for BECKMAN COULTER CZE 2000 SYSTEM 465500 manufactured by Beckman Coulter, Inc..
[195986]
Customer states that a significant igg kappa monoclonal protein was not identified on apt when using the cze electrophoresis system. When rerun using the paragon gel electrophoresis system, the monoclonal fraction was identified. The cze system labeling describes the potential for the system to miss a small monoclonal fractions. Monoclonal proteins may be indicative of serious illness and disease states and a significant monoclonal that is not identified could lead to incorrect diagnosis or inappropriate treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-1999-00005 |
| MDR Report Key | 252143 |
| Report Source | 05,06 |
| Date Received | 1999-11-23 |
| Date of Report | 1999-11-18 |
| Date of Event | 1999-10-11 |
| Date Mfgr Received | 1999-10-13 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 1999-12-03 |
| 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 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| 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 | BECKMAN COULTER CZE 2000 SYSTEM |
| Generic Name | COLUMN ELECTROPHORESIS SYSTEM |
| Product Code | JZS |
| Date Received | 1999-11-23 |
| Model Number | CZE 2000 |
| Catalog Number | 465500 |
| Lot Number | * |
| 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 | 244194 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 200 KRAEMER BLVD. BREA CA 928228000 US |
| Baseline Brand Name | BECKMAN COULTER CZE |
| Baseline Generic Name | CAPILLARY ZONE ELECTROPHORESIS |
| Baseline Model No | CZE 2000 |
| Baseline Catalog No | 465500 |
| Baseline Device Family | ELECTROPHORESIS SYSTEM FAMILY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953077 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-23 |