MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2004-02-11 for ORTHO SUMMIT SAMPLE HANDLING SYSTEM 7003009 936400 manufactured by Hamilton Bonaduz Ag.
[28477046]
No sample/no error message was not generated by the summit. Low sample/diluent in well h12 during pipetting. No death or serious injury was associated with this incident. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2004-00056 |
| MDR Report Key | 5152196 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2004-02-11 |
| Date of Report | 2004-02-10 |
| Date of Event | 2004-01-17 |
| Date Mfgr Received | 2004-01-17 |
| Date Added to Maude | 2015-10-15 |
| 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 | 3 |
| Manufacturer Contact | LAURA VALLUCCI, PHD |
| Manufacturer Street | 1001 US HIGHWAY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORTHO SUMMIT SAMPLE HANDLING SYSTEM |
| Generic Name | SAMPLE PIPETTOR |
| Product Code | GJG |
| Date Received | 2004-02-11 |
| Model Number | 7003009 |
| Catalog Number | 936400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAMILTON BONADUZ AG |
| Manufacturer Address | BONADUZ CH 7402 SZ CH 7402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-11 |