MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-17 for COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER 6605526 manufactured by Beckman Coulter, Inc..
[448293]
A customer contacted beckman coulter regarding erroneous rbc, hemoglobin (hgb), and hematocrit (hct) results generated by the coulter hmx hematology analyzer with autolader. Per customer, on 04/07/06 a cross-match specimen was collected from a patient and tested for cbc. Rbc, hgb and hct results were higher when compared with results obtained a day earlier; the customer re-tested the patient sample and the rebc hgb and hct results were in the same range as in the 1st run of 04/07/06; an hour later, the customer collected a fresh sample for the patient and tested for cbc; rhe rbc, hgb and hct results were totally different, but closely mathced results from 1 day before; the sample was re-tested and rbc, hgb, and hct repeated results mathced the results from event date. For the actual rbc, hgb, and hct results please see b6. Baed on available information, there was no affect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2006-00017 |
| MDR Report Key | 716590 |
| Report Source | 05 |
| Date Received | 2006-05-17 |
| Date of Report | 2006-05-17 |
| Date of Event | 2006-04-07 |
| Date Mfgr Received | 2006-04-18 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2006-05-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NORA ZERUNIAN, MGR |
| 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 | 7149613634 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKH |
| Date Received | 2006-05-17 |
| Model Number | 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 | 705658 |
| 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 | 2006-05-17 |