MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-18 for COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER 6605526 manufactured by Beckman Coulter, Inc..
[16722361]
A customer contacted beckman coulter regarding erroneous hemoglobin (hgb) results generated by the coulter hmx hematology analyzer with autoloader. Patient a, b, and c samples were tested for hgb and results of: 15. 2g/dl, 11. 5g/dl and 10. 8g/dl were obtained for patients a to c respectively. Some of the hgb results were printed with customer defined "l" flag. "l - result is lower than your reference interval low limit. Follow your laboratory's policies for reviewing the sample. " the hgb results were reported out of the lab and questioned by a physician. The orginal samples were re-tested for hgb and the repeated results were: 16. 2g/dl, 12. 4g/dl, and 11. 9g/dl for patients a to c respectively. The results were corrected. Based on available information, there was no impact to the pt treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[16909272]
Investigation summary: qc was performed before and after the event. The instrument is currently performing within qc specifications. The erroneous results occurred in primary mode of operation. A field service engineer (fse) was dispatched to the customer's lab. The fse replaced blood sample valve (bsv) actuator and cleaned the bsv ports. The fse verified repair per established procedures; the results meet published performance specifications. Hardware issue addressed by the fse may have contributed to this event. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2006-00065 |
| MDR Report Key | 801710 |
| Report Source | 05 |
| Date Received | 2006-12-18 |
| Date of Report | 2006-12-18 |
| Date of Event | 2006-11-26 |
| Date Mfgr Received | 2006-12-01 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2007-01-10 |
| 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 | NORA ZEROUNIAN, MANAGER |
| Manufacturer Street | 200 S KRAEMER BLVD PO BOX 8000, MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2006-12-18 |
| Model Number | AUTOLOADER |
| Catalog Number | 6605526 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 789229 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US |
| Baseline Brand Name | COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER |
| Baseline Generic Name | HEMATOLOGY ANALYZER |
| Baseline Model No | AUTOLOADER |
| Baseline Catalog No | 6605526 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-18 |