MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-23 for AUTOREADER II 7003009 936000 manufactured by Ortho-clinical Diagnostics.
[299550]
The customer reported that autoreader ii occasionally gave negative absorbances on entire row of a microwell plate. No error was reported. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2002-00706 |
| MDR Report Key | 435067 |
| Date Received | 2002-12-23 |
| Date of Report | 2002-12-18 |
| Date of Event | 2002-11-22 |
| Date Facility Aware | 2002-12-06 |
| Report Date | 2002-12-18 |
| Date Reported to Mfgr | 2002-12-06 |
| Date Added to Maude | 2003-01-02 |
| 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 | AUTOREADER II |
| Generic Name | MICROWELL PLATE READER |
| Product Code | LRH |
| Date Received | 2002-12-23 |
| Model Number | 7003009 |
| Catalog Number | 936000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 424018 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| 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 | 2002-12-23 |