MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-31 for COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER HMX WITH AUTOLEADER 6605526 manufactured by Beckman Coulter, Inc..
[382338]
A customer contacted beckman coulter regarding erroneously low platelet (plt) results from two (2) different patients that were generated by the coulter hmx with autoloader analyzer. The plt result from patient a was 49 x 10 to the third power cells/ul. The plt result from patient b was 77 x 10 to the third power cells/ul. The customer indicated that the plt results were not reported out of the lab. The customer indicated that the coulter hmx with autoloader instrument was used only to compare the plt results with the results obtained earlier from a different instrument. The customer indicated that the plt results from coulter hmx with autoloader closely matched the results of the different intrument (51 x 10 to the third power cells/ul respectively). The customer then performed a manual slide review for plt. The plt result for patient a was 200-250. The plt result for patient b was approximately 180. No additional event information was provided. The customer indicated that there was no change in patients treatment that can be attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2005-00021 |
| MDR Report Key | 609982 |
| Report Source | 05 |
| Date Received | 2005-05-31 |
| Date of Report | 2005-05-31 |
| Date of Event | 2005-04-22 |
| Date Mfgr Received | 2005-05-05 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2005-06-06 |
| 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 | NANCY JOHNSON, GROUP MANAGER |
| Manufacturer Street | 200 S. KRAEMER BOULEVARD 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 |
| Remedial Action | IN |
| 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 | HEMETOLOGY ANALYZER |
| Product Code | GKH |
| Date Received | 2005-05-31 |
| Model Number | HMX WITH AUTOLEADER |
| 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 | 599790 |
| 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 | HEMETOLOGY ANALYZER |
| Baseline Model No | HMX WITH AUTOLE |
| Baseline Catalog No | 6605526 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-31 |