MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-27 for ORTHO HBC ELISA 2400T 7003009 933275 manufactured by Ortho-clinical Diagnostics.
[258904]
Customer reported that individual strips on ortho hbc microwell plates are becoming dislodged and fall out of the plate during testing. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2002-00643 |
| MDR Report Key | 414027 |
| Date Received | 2002-08-27 |
| Date of Report | 2002-08-22 |
| Date of Event | 2002-08-02 |
| Date Facility Aware | 2002-08-02 |
| Report Date | 2002-08-22 |
| Date Reported to Mfgr | 2002-08-02 |
| Date Added to Maude | 2002-09-04 |
| 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 HBC ELISA 2400T |
| Generic Name | ASSAY KIT |
| Product Code | LQI |
| Date Received | 2002-08-27 |
| Model Number | 7003009 |
| Catalog Number | 933275 |
| Lot Number | CHK411 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 403066 |
| 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 | 2002-08-27 |