MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-14 for COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER 660500 manufactured by Beckman Coulter, Inc..
[303353]
According to co's customer, during a routine qc procedure in the afternoon, they noticed the ac-t diff2 instrument generating a high platelet result. The platelet background result was high out of range in the afternoon [>140 x 103 cells/ul]. The platelet control values for the afternoon were high out of range. The customer suspects that sample results may have been reported during this time. No pt info/results were provided by the customer. There has been no change to pt treatment that can be attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2003-00016 |
| MDR Report Key | 490720 |
| Report Source | 05 |
| Date Received | 2003-10-14 |
| Date of Report | 2003-10-14 |
| Date of Event | 2003-08-20 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2003-10-24 |
| 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-C206 |
| 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 | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | GKH |
| Date Received | 2003-10-14 |
| Model Number | AC-T DIFF 2 |
| Catalog Number | 660500 |
| 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 | 479447 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US |
| Baseline Brand Name | COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER |
| Baseline Generic Name | AUTOMATED DIFFERNTIAL CELL COUNTER |
| Baseline Model No | AC-T DIFF 2 |
| Baseline Catalog No | 600500 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-14 |