MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-16 for ORTHO SUMMIT SAMPLE HANDLING SYSTEM 135028 936400 manufactured by Hamilton Bonaduz Ag.
[171149]
The customer reported that while running a hepatitis core assay, summit sample handler did not pipette sample or reagent into well position a11 and did not give an error message. An ortho field service engineer was dispatched. No death or serious injury was associated with this event. This report corresponds to ortho-clinical diagnostics complaint number 00-01606-04.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2000-00151 |
| MDR Report Key | 278748 |
| Date Received | 2000-05-16 |
| Date of Report | 2000-04-06 |
| Date of Event | 2000-03-29 |
| Date Facility Aware | 2000-04-06 |
| Report Date | 2000-05-01 |
| Date Reported to Mfgr | 2000-05-01 |
| Date Added to Maude | 2000-05-24 |
| 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 | 0 |
| 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 HANDLER |
| Product Code | JTC |
| Date Received | 2000-05-16 |
| Model Number | 135028 |
| Catalog Number | 936400 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 269763 |
| Manufacturer | HAMILTON BONADUZ AG |
| Manufacturer Address | * BONADUZ SZ CH-7402 |
| Baseline Brand Name | ORTHO SUMMIT SAMPLE HANDLING SYSTEM |
| Baseline Generic Name | DILUTOR/DISPENSER |
| Baseline Model No | 135028 |
| Baseline Catalog No | 936400 |
| Baseline ID | NA |
| Baseline Device Family | SAMPLE HANDLER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K871945 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Brand Name | * |
| Product Code | LRH |
| Date Received | 2000-05-16 |
| Implant Flag | N |
| Device Sequence No | 2 |
| Device Event Key | 269764 |
| Baseline Brand Name | ORTHO ELISA BAR CODE READER II |
| Baseline Generic Name | BAR CODE READER |
| Baseline Model No | 9720C01,D01,E01 |
| Baseline Catalog No | 935240 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-16 |