MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-20 for ORTHO ELISA BAR CODE READER II 9720C01,D01,E01,F01 935240 manufactured by Intermec Corp.
[202003]
The customer reported while running an hcv assay, using a hand held intermec barcode wand, read a sample barcode incorrectly as "013q09218" instead of "013lq09206". No death or serious injury was associated with this event. Log files are under review by product support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002917 |
| MDR Report Key | 309877 |
| Date Received | 2000-12-20 |
| Date of Report | 2000-12-05 |
| Date of Event | 2000-12-05 |
| Date Added to Maude | 2000-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO ELISA BAR CODE READER II |
| Generic Name | BAR CODE READER |
| Product Code | LRH |
| Date Received | 2000-12-20 |
| Model Number | 9720C01,D01,E01,F01 |
| Catalog Number | 935240 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 299796 |
| Manufacturer | INTERMEC CORP |
| Manufacturer Address | 100 PASSAIC AVE GREENBROOK CORPORATE CENTER FAIRFIELD NJ 07004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-12-20 |