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 LH 750 6605632 manufactured by Beckman Coulter, Inc..
[371057]
A customer contacted beckman coulter regarding erroneously low platelet (plt) results from three (3) different patients that were generated by the coulter lh 750 instrument. The plt result from patient a was 51 x 10 to the third power cells/micro liter. The plt result from patient b was 81 x 10 to the third power cells/micro liter. The pt result from patient c was 59 x 10 to the third power cells/micro liter. The customer re-tested the patients (a and b) original samples for plt on another instrument in their lab. Data for patient c on this instrument was not provided by the account. The plt result from patient a was 49 x 10 to the third power cells/micro liter. The plt result from patient b was 77 x 10 to the third power cells/micro liter. The customer then performed a manual slide review for plt. The plt result for patient a was 200-205. The plt result for patient b was approximately 180. The plt result for patient c was 120-140. 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 | 1061932-2005-00020 |
| MDR Report Key | 609965 |
| Report Source | 05 |
| Date Received | 2005-05-31 |
| Date of Report | 2005-05-31 |
| Date of Event | 2005-04-22 |
| Date Mfgr Received | 2005-05-02 |
| Device Manufacturer Date | 2003-05-01 |
| 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 LH 750 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKH |
| Date Received | 2005-05-31 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| 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 | 599773 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US |
| Baseline Brand Name | COULTER LH 750 |
| Baseline Generic Name | HEMATOLOGY ANALYZER |
| Baseline Model No | LH 750 |
| Baseline Catalog No | 6605632 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-31 |