MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-08 for ORTHO ELISA BAR CODE READER II 9720C01, D01, E01, F01 935240 manufactured by Intermec Corp.
[21694960]
The customer reported while running a hepatitis surface antigen assay, using a hand held intermec barcode wand read a sample barcode incorrectly. Software support determined the probable cause of the barcode misread was due to the barcode wand. No death or serious injury was associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2001-00455 |
| MDR Report Key | 332741 |
| Date Received | 2001-05-08 |
| Date of Report | 2001-04-25 |
| Date of Event | 2001-04-25 |
| Date Facility Aware | 2001-04-25 |
| Report Date | 2001-04-25 |
| Date Reported to Mfgr | 2001-05-08 |
| Date Added to Maude | 2001-05-17 |
| 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 | 2001-05-08 |
| Model Number | 9720C01, D01, E01, F01 |
| Catalog Number | 935240 |
| 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 | 322109 |
| Manufacturer | INTERMEC CORP |
| Manufacturer Address | 100 PASSAIC AVE GREENBROOK CORP CENTER FAIRFIELD NJ 07004 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 | 2001-05-08 |