MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-31 for ORTHO ELISA BAR CODE READER II 9720C01 935240 manufactured by Intermec Corp.
[172178]
The customer reported while using a hand held intermec barcode wand, device read a sample barcode incorrectly as "495235397" instead of "049gr35397". A hiv-1 p24 antigen assay was being run at the time. No death or serious injury was associated with this event. This report corresponds to ortho-clinical diagnostics complaint number 00-01185-03.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2000-00135 |
| MDR Report Key | 272316 |
| Date Received | 2000-03-31 |
| Date of Report | 2000-03-13 |
| Date of Event | 2000-03-13 |
| Date Facility Aware | 2000-03-13 |
| Report Date | 2000-03-30 |
| Date Reported to Mfgr | 2000-03-30 |
| Date Added to Maude | 2000-04-07 |
| 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 | 2000-03-31 |
| Model Number | 9720C01 |
| 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 | 263623 |
| Manufacturer | INTERMEC CORP |
| Manufacturer Address | GREENBROOK CORPORATE CENTER 100 PASSAIC AVE FARIFIELD NJ 07004 US |
| Baseline Brand Name | ORTHO ELISA BARCODE READER II |
| Baseline Generic Name | BAR CODE READER |
| Baseline Model No | 9720C01 |
| Baseline Catalog No | 935240 |
| Baseline ID | NA |
| Baseline Device Family | BAR CODE READER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-31 |