MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-31 for ORTHO ELISA BAR CODE READER II 9720C01, D01, E01, F01 935240 manufactured by Intermec Corporation.
[213187]
The customer reported that a barcode misread occurred while running at htlv i/ii assay. Intermec wand reader was in use at the time the misread occurred. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2002-00511 |
| MDR Report Key | 375503 |
| Date Received | 2002-01-31 |
| Date of Report | 2002-01-02 |
| Date of Event | 2001-12-30 |
| Date Facility Aware | 2002-01-02 |
| Report Date | 2002-01-31 |
| Date Reported to Mfgr | 2002-01-31 |
| Date Added to Maude | 2002-02-08 |
| 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 ELISA BAR CODE READER II |
| Generic Name | BAR CODE READER |
| Product Code | LRH |
| Date Received | 2002-01-31 |
| Model Number | 9720C01, D01, E01, F01 |
| Catalog Number | 935240 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 364609 |
| Manufacturer | INTERMEC CORPORATION |
| Manufacturer Address | 80 MAIN STREET WEST ORANGE NJ 07052 US |
| Baseline Brand Name | ORTHO ELISA BAR CODE READER II |
| Baseline Generic Name | BAR CODE READER |
| Baseline Model No | 9720C01, D01, E |
| Baseline Catalog No | 935240 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-31 |