MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for ORTHO SUMMIT SAMPLE HANDLING SYSTEM 7003009 936400 manufactured by Hamilton Bonaduz Ag.
[611877]
The ortho summit sample handling system instrument reportedly did not pipette sample/reagent and did not generate an error message. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2250051-2007-70012 |
MDR Report Key | 830713 |
Date Received | 2007-01-18 |
Date of Report | 2007-01-18 |
Date of Event | 2006-12-19 |
Date Added to Maude | 2007-03-27 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | MEDICAL TECHNOLOGIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ORTHO SUMMIT SAMPLE HANDLING SYSTEM |
Generic Name | SAMPLE PIPETTER |
Product Code | JTQ |
Date Received | 2007-01-18 |
Model Number | 7003009 |
Catalog Number | 936400 |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 818065 |
Manufacturer | HAMILTON BONADUZ AG |
Manufacturer Address | * BONADUZ SZ CH 7402 |
Baseline Brand Name | ORTHO SUMMIT SAMPLE HANDLER |
Baseline Generic Name | SAMPLE HANDLER |
Baseline Model No | 7003009 |
Baseline Catalog No | 936400 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2007-01-18 |