MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-01 for AUTO READER II 6900196 936000 manufactured by Ortho-clinical Diagnostics.
[316756]
The customer reported that they are intermittently getting negative ods on processed microwell plates while using autoreader ii. This reportedly is not happening on similar readers and does not affect every 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 | 2250051-2003-00683 |
| MDR Report Key | 452219 |
| Date Received | 2003-04-01 |
| Date of Report | 2003-03-31 |
| Date of Event | 2003-03-20 |
| Date Facility Aware | 2003-03-20 |
| Report Date | 2003-03-31 |
| Date Reported to Mfgr | 2003-03-20 |
| Date Added to Maude | 2003-04-09 |
| 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 | AUTO READER II |
| Generic Name | PLATE READER |
| Product Code | LRH |
| Date Received | 2003-04-01 |
| Model Number | 6900196 |
| Catalog Number | 936000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 441214 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Baseline Brand Name | AUTO READER II |
| Baseline Generic Name | PLATE READER |
| Baseline Model No | 6900196 |
| Baseline Catalog No | 936000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-04-01 |