MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for INTERMEC BARCODE READER 6900201 935240 manufactured by Ortho-clinical Diagnostics.
[358447]
After scanning a sample id using the intermec barcode reader, it was discovered that a misread occurred across three different assays. No error was generated. No death or serious injury was associated with this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2003-01293 |
| MDR Report Key | 508681 |
| Date Received | 2003-11-24 |
| Date of Report | 2003-11-04 |
| Date of Event | 2003-09-04 |
| Date Facility Aware | 2003-09-04 |
| Report Date | 2003-11-04 |
| Date Added to Maude | 2004-01-30 |
| 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 | 3 |
| 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 | INTERMEC BARCODE READER |
| Generic Name | BARCODE READER |
| Product Code | LRH |
| Date Received | 2003-11-24 |
| Model Number | 6900201 |
| Catalog Number | 935240 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 497628 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-24 |