MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-07-22 for COULTER LH 750 6605632 manufactured by Beckman Coulter, Inc..
[19155176]
According to the customer, an incorrect platelet result was generated by an lh 750 instrument. The incorrect platelet result from sample a (collected in an edta sample tube) was 9,000cells/ul. The incorrect platelet result was reported out of the lab. The customer indicated the resultwas determined to be incorrect after the manual slide review did not agree with the (sample a) platelet result from the lh750. The reported platelet result was questioned by the physician. The customer indicated that a manual slide review was conducted on sample a. A higher platelet count was obtained from the manual slide review. An additioal sample (b) was collected from the pt after the higher platelet result was reviewed. The sample (b) was collected in a citrate sample tube. The platelet result from sample b was 134,000cell/ul. The customer did not provide additional information regarding the pt results from sample a or sample b. The customer indicated that there has no change to pt treatment that can be attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2004-00010 |
| MDR Report Key | 594018 |
| Report Source | 05 |
| Date Received | 2004-07-22 |
| Date of Report | 2004-07-22 |
| Date of Event | 2004-06-23 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2005-04-25 |
| 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 | ANNE SABER |
| Manufacturer Street | 11800 SW 147TH AVENUE MAIL STOP: 32-C06 |
| Manufacturer City | MIAMI FL 331169015 |
| Manufacturer Country | US |
| Manufacturer Postal | 331169015 |
| Manufacturer Phone | 3053802618 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2004-07-22 |
| 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 | 583845 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. 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 | 2004-07-22 |