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 |