MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-19 for COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HMX WITH AUTOLOADER 6605526 manufactured by Beckman Coulter, Inc..
[16400854]
Erroneous cbc {wbc, rbc, hemoglobin (hcb), platelet (plt)} results generated by the coulter hmx with autoloader analyzer. Per customer, the erroneous cbc results were generated in a secondary mode. The cbc results from the secondary mode were believed to be erroneous when compared with the results from the primary mode. The wbc results were: 6. 0 x 10 3 cells/ul in the primary mode, and 4. 4 x 10 3 cells/ul in the secondary mode. The rbc results were: 4. 40 x 10 6 cell/ul in the primary mode, and 5. 62 x 10 6 cells/ul in the secondary mode. The hbg results were: 13. 0g/dl in the primary mode, and 10. 7g/dl in the secondary mode. The plt results were: 242 x 10 3 cells/ul in the primary mode, and 355 x 10 3 cell/ul in the secondary mode. Based on available info, there was no affect to pt treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2006-00012 |
| MDR Report Key | 702567 |
| Report Source | 05 |
| Date Received | 2006-04-19 |
| Date of Report | 2006-04-19 |
| Date of Event | 2006-03-30 |
| Date Mfgr Received | 2006-03-30 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2006-04-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ERI HIRUMI, GROUP MANAGER |
| Manufacturer Street | 200 S. KRAEMER BLVD P.O BOX 8000 MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149614389 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKH |
| Date Received | 2006-04-19 |
| Model Number | HMX WITH AUTOLOADER |
| Catalog Number | 6605526 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 691696 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US |
| Baseline Brand Name | COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER |
| Baseline Generic Name | HEMATOLOGY ANALYZER |
| Baseline Model No | HMX WITH AUTOLO |
| Baseline Catalog No | 6605526 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-19 |